Others titles

Post-Approval Studies
Medical Device Post-Approval Studies

Keywords

CDRH and Applicants
CDRH’s Post-Approval Studies
Post-Approval Studies
PAS
Post-Approval Device

FDA Post Approval Studies Database

Name: FDA Post Approval Studies Database
Creator: John Snow Labs

The Post-Approval Studies (PAS) Database identifies the reporting status of PAS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH’s effort to ensure that all PAS commitments are fulfilled in a timely manner.

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Description

CDRH’s Post-Approval Studies Program ensures that methodologies are well-designed and conducted effectively, efficiently and in the least burdensome manner. In 2005, the Division of Epidemiology (DEPI) in CDRH’s Office of Surveillance and Biometrics (OSB) assumed responsibility for overseeing the program. Along with OSB, other CDRH offices including the Office of Device Evaluation (ODE), and the Office of In-Vitro Diagnostics and Radiological Health (OIR), share PAS Program responsibilities for design, tracking, oversight, and review of these mandated studies. Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.

CDRH has established the Post-Approval Studies Database to share general information regarding each PAS ordered since January 1, 2005, provides the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s current reporting status for each submission due. The database refreshes every Sunday with any new or revised information on study protocol parameters (e.g., patient population), overall study status, or information related to the review of data from interim or final reports.

About this Dataset

Data Info

Date Created	2005
Last Modified	2022-05-30
Version	2022-05-30
Update Frequency	Irregular
Temporal Coverage	1991-09 to 2022-05-30
Spatial Coverage	United States
Source	John Snow Labs; Food and Drug Administration (FDA);
Source License URL
Source License Requirements	N/A
Source Citation	N/A
Keywords	CDRH and Applicants, CDRH’s Post-Approval Studies, Post-Approval Studies, PAS, Post-Approval Device
Other Titles	Post-Approval Studies, Medical Device Post-Approval Studies

Data Fields

Name	Description	Type	Constraints
Application_Number	PAS Application Number	string	required : 1
Applicant_Name	The Applicant Name	string	required : 1
Device_Name	Medical Device Name	string	required : 1
Medical_Specialty	Medical Specialty of the Medical Device	string	required : 1
Date_PMA_Approved	Premarket-Approval (PMA) Approved Date	date	required : 1
Study_Name	Medical Device Study Name	string	required : 1
Protocol_Accepted_Date	The Protocol Accepted Date	date	-
Current_Protocol_Accepted_Date	The Current Protocol Accepted Date	date	-
Study_Status	The status of the study determined by the FDA After the review of a supplement with a protocol or of an interim or final report.	string	-
Study_Progress_Reason	Medical device study progress reason	string	-
Study_Design	Medical device study design	string	-
Is_Study_Involve_Follow_Up_Of_Premarket_Cohort	Study involve follow-up of premarket cohort	boolean	-
Data_Source	The Data source	string	enum : Array ( [0] => Admin Database [1] => External Registry [2] => New Data Collection [3] => Other Data Source [4] => Sponsor Registry )
Comparison_Group	Medical device comparison group	string	-
Analysis_Type	Medical device analysis type	string	enum : Array ( [0] => Analytical [1] => Descriptive ) maxLength : 11
Study_Population	Medical device study population	string	-
Study_Design_Description	Medical device study design description	string	-
Study_Population_Description	Medical device study population description	string	-
Sample_Size	Study sample size	string	-
Data_Collection	Data collection	string	-
Followup_Visits_and_Length_of_Followup	Followup Visits and Length of Followup	string	-
Actual_Number_of_Patients_Enrolled	Actual Number of Patients Enrolled	string	-
Actual_Number_of_Sites_Enrolled	Actual Number of Sites Enrolled	string	-
Patient_Followup_Rate	Patient Followup Rate	string	-
Final_Safety_Findings	Final medical device safety findings	string	-
Final_Effectiveness_Findings	Final effectiveness findings	string	-
Study_Strengths_and_Weaknesses	Medical device study strengths and weaknesses	string	-
Recommendations_for_Labeling_Changes	Recommendations for medical device labeling changes	string	-
Interim_Safety_Information	Safety information of the interim	string	-

Data Preview

Application Number

Applicant Name

Device Name

Medical Specialty

Date PMA Approved

Study Name

Protocol Accepted Date

Current Protocol Accepted Date

Study Status

Study Progress Reason

Study Design

Is Study Involve Follow Up Of Premarket Cohort

Data Source

Comparison Group

Analysis Type

Study Population

Study Design Description

Study Population Description

Sample Size

Data Collection

Followup Visits and Length of Followup

Actual Number of Patients Enrolled

Actual Number of Sites Enrolled

Patient Followup Rate

Final Safety Findings

Final Effectiveness Findings

Study Strengths and Weaknesses

Recommendations for Labeling Changes

Interim Safety Information

P170038/ PAS001

Abbott

CentriMag Circulatory Support System

Cardiovascular

2019-12-06

CentriMag FTW PAS

2020-05-22

Study Pending

Prospective Cohort Study

False

New Data Collection

Objective Performance Criterion

Analytical

Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21

P160030/ PAS001

ABBOTT DIABETES CARE INC.

Freestyle Libre Flash Glucose Monitoring System

Clinical Chemistry

2017-09-27

FreeStyle Libre Flash Glucose Monitoring

2017-12-08

2018-09-25

Progress Adequate

Prospective Cohort Study

False

New Data Collection

Device Subjects Serve as Own Control

Analytical

Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21

This is a one-year prospective; multi-center; nonrandomized; single-arm; post-approval study of the FreeStyle Libre 14 Day Flash CGM intended to characterize the safety of the device when used in people with type 1 and type 2 diabetes non-adjunctively in ages 18 years and up.Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using the FreeStyle Libre 14 Day Flash for 6 months (intervention phase). Subjects will maintain a diary/log book of adverse events during each phase. Assessment ofadverse events will occur via self-reporting at each monthly visit and/or phone call. Subjects will also complete a Quality of Life questionnaire at the completion of the control phase and the intervention phase. Up to 920 subjects will be enrolled in up to 10 sites to obtain at least 736subjects who complete the study. The purpose of this study is to characterize the safety of the Libre 14 Day Flash Glucose Monitoring System when used in the intended use population.

Adult (18 years of age and up) with type 1 and type 2 diabetes that meet the inclusion/exclusion criteria will be studied.The device is investigational in ages 4-17 years. The 4-17 year age group will also be studied under an approved IDE G170269/S001.Inclusion Criteria:Subjects will be considered for enrollment in the study if they meet all of the following criteria:1. Subject must be at least 18 years of age2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus3. Subject is currently using SMBG for managing their diabetes4. Subject must be able to read and understand English and/or Spanish5. In the investigators opinion; the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol6. Subject must have access to an internet connected for uploading data from the blood glucose meter and FreeStyle Libre system.7. Subject must be willing and able to provide written signed and dated informed consent and assent when appropriate.Exclusion Criteria:1. Subject is a member of the Site Staff2. Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes3. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.4. Subject is pregnant at the time of enrollment5. Subject is on dialysis at the time of enrollment6. Subject has concomitant medical condition which; in the opinion of the investigator; could interfere with the study or present a risk to thesafety or welfare of the subject or study staff7. Subject currently participating in another clinical trial8. Subject is unsuitable for participation due to any other cause as determined by the investigator.

Up to 920 subjects will be enrolled

Primary Endpoint:An analysis of the rate of severe hypoglycemic andhyperglycemic events will compare the intervention phase(approximate days 180 to 365) to the control phase(approximate days 1-180).Secondary Endpoints:BG frequency in the control and intervention phasesScan frequency in the intervention phaseChange in HbA1cDTSQ (Quality of Life Questionnaire).

Follow-up visits are scheduled throughout the study period for 12 months.

P150004/ PAS001

Abbott Medical

Axium Neurostimulator System

Neurology

2016-02-11

F/U Axium Neurostimulator System (FANS)

2016-05-26

2017-07-26

Progress Adequate

Prospective Cohort Study

False

New Data Collection

Objective Performance Criterion

Analytical

Adult: >21

The FANS PAS is a prospective; multicenter; single arm; observational post-approval study to be conducted at up to 45 centers in the United States in order to demonstrate continued safety and effectiveness of the Axium Neurostimulator System or the Proclaim DRG Neurostimulator System. The primary objective of the FANS PAS is to demonstrate that the proportion of serious adverse events (SAEs) at 12 months for subjects who receive a permanent implant is lower than a pre-specified performance goal. Secondary objectives of the FANS PAS are to evaluate change in overall pain intensity; change in physical function and change in quality of life over the study period.

A maximum of 426 adult subjects with moderate to severe chronic; intractable pain of the lower limbs due to CRPS types I and II will undergo a trial of the neurostimulator system at up to 45 study sites in the United States.Inclusion Criteria: Male or female between the ages of 22 and 75 years. Moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II. Baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment. Willing and able to comply with the study requirements. Able to provide written informed consent.Exclusion criteria: Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators. Subject is currently involved in medically-related litigation; including workers compensation. Subject has a life expectancy of less than one year. Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator. Subject has; or plans to have; a spinal cord stimulation system or infusion pump system implanted. Subject has; or plans to have; a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted. Subject is considered a poor surgical or study candidate; which may include; but is not limited to the following: any medical; social; or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.

The sample size required to reject the null hypothesis for the primary endpoint at the 5% significance level with 80% power assuming a 12-month SAE rate of 10.5% is 287 subjects receiving the permanent Axium or Proclaim DRG IPG. Assuming an attrition rate of 25% from trial to permanent Axium or Proclaim DRG IPG implant; and an attrition rate of 10% from permanent implant to 12-month follow-up; a total of 426 (=287/0.9/0.75)subjects will be implanted with a trial system. The target number of subjects for permanent Axium or Proclaim DRG IPG implants is 319; and the target number of subjects for the primary endpoint analysis is 287.

Primary EndpointThe primary endpoint is the 12-month SAE rate for subjects receiving the permanent DRG IPG.Secondary Endpoints Percent change from baseline to 12 months post-permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS)Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS-29 Profile Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health ScaleDescriptive EndpointsSafety Proportion of subjects with device; procedure or stimulation related SAEs and non-SAEs among subjects who receive the permanent implant Proportion of subjects who have AEs related to the trial implant procedure among subjects who fail the trial neurostimulator phase Summary of procedure-related SAEs and non-SAEs by implanter experienceEffectiveness Change from baseline to 1; 3; and 6 months post permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS) Change from baseline to 1; 3; and 6 months post permanent implant for physical function measured using the PROMIS-29 Profile Change from baseline to 1; 3; and 6 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale Change from baseline to 1; 3; 6 and 12 months post-permanent implant for neuropathic pain measured using the Neuropathic Pain Scale (NPS) Change from baseline to 1; 3; 6 and 12 months post-permanent implant for sleep disturbance; anxiety; depression; fatigue; ability to participate in social roles and activities; paininterference and pain intensity measured using the PROMIS-29 Profile Patient Global Impression of Change (PGIC) at 1; 3; 6 and 12 months post-permanent implantAdditional DataAll descriptive endpoints above will be examined at 18 and 24 months for all subjects with evaluable data for those study visits. Additional data; including but not limited to; percentage of subjects achieving at least a 30% and 50% pain reduction; demographics; paresthesia coverage and intensity; subject satisfaction; programming parameters; implant procedure information; and system information may be compiled.

up to 24 months

P040040/ PAS001

Abbott Medical

AMPLATZER MUSCULAR VSD OCCLUDER

Cardiovascular

2007-09-07

5 year long term (IDE)

2007-09-07

Terminated

Other reason

Prospective Cohort Study

True

Sponsor Registry

Concurrent Control

Descriptive

Child: 2-12 yrs; Adolescent: 13-18 yrs; Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21

This study will provide long-term follow-up of forty-three subjects from the premarket cohort that have been designated as High Risk.

This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt; pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.

43 patients; 21 sites

Safety endpoints include adverse events.

Annual office visits were required out to 5 years.

24%

A total of 35 overall events were reported in 20 of 43 subjects (46.5%). The most frequently reported event was hypotension which was reported in 11.6% of subjects (5 reports in 5 of 43 subjects).

Strengths: Lessons learned on requesting for long term follow-up consent at tiem of IDE enrollmentWeaknesses: Extremely low follow-up of the cohort.

No labeling changes were recommended.

The study was terminated early due a low follow-up rate

P040040/ PAS002

Abbott Medical

AMPLATZER MUSCULAR VSD OCCLUDER

Cardiovascular

2007-09-07

Post Approval Study

2007-09-07

2016-03-18

Progress Inadequate

Subject enrollment milestones not met

Prospective & Retrospective Study

False

New Data Collection

Historical Control

Analytical

Infant: 29 days-2 yrs; Child: 2-12 yrs; Adolescent: 13-18 yrs; Transit. Adolescent A (distinctively) : 18-21 yrs; Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21; All Pediatric Patients: 0-21 yrs

This study is a prospective; non-randomized; multi-site clinical study. The primary safety objective is to evaluate the proportion of subjects experiencing a major (serious) adverse event within 12 months of the procedure. The effectiveness objective is to evaluate the proportion of subjects whom experience technical success; closure success; and acute procedure success.

This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt; pulmonary hypertension and or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and or based on overall medical condition. Eligible patients can be enrolled retrospectively.The comparison group is the Historical Control.

One hundred (100) subjects will be enrolled at up to 50 U.S. sites and additional sites in Europe and Canada.If subject follow-up drops below 80%; additional subjects will be enrolled to ensure a final population of 80 subjects either meet a defined endpoint or are followed for five years.

Primary safety endpoint:Any major (serious) adverse event within 12 months of the procedure. A serious adverse event is defined as any untoward medical occurrence that: results in death; is a life-threatening adverse event; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a medically significant event.Primary effectiveness endpoints: Technical Success Acute Procedure Success Shunt Closure Success at 12 months

Each study subject receiving a device will be followed for 60 months post-procedure; unless the device is explanted. Follow-up assessments will be conducted at 30 days; 6 months ; one year; and annually until the five-year visit is complete. If the delivery system enters the subjectâs body in an attempt to place a device but no device is implanted during the initial procedure; the subject will be discontinued from the study after a 30-day adverse event collection period.If the device explant occurs before the 12-month visit and a SAE is associated with the device explant; the subject will be discontinued on the date the device is explanted. (In this case; the subject is considered a failure for all endpoints except Technical Success.)If a device explant is not associated with a SAE; the subject will continue to be followed through the 12-month visit. The subject will then be discontinued at the 12-month visit. If a subject has a device explanted after the 12-month visit; the subject will be discontinued on the date of the explant procedure.

P020024 S052 / PAS001

Abbott Medical

AMPLATZER Piccolo Occluder

Cardiovascular

2019-01-11

Continued FU of IDE/CAP cohort

2019-01-11

Progress Adequate

Prospective Cohort Study

True

New Data Collection

No Control

Descriptive

Neonate: 1-28 days; Infant: 29 days-2 yrs; Child: 2-12 yrs

P100009 S028 / PAS001

ABBOTT VASCULAR INC.

MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System

Cardiovascular

2019-03-14

Cont f/u of the COAPT Trival Pivotal Cohort

Progress Adequate

Prospective Cohort Study

True

New Data Collection

Concurrent Control

Descriptive

Adult: >21

Continued follow-up of all living subjects who were enrolled in the COAPT Trial pivotal cohort. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.

All living subjects who were enrolled in the IDE pivotal cohort.

All living subjects

The key safety and effectiveness endpoints include all-cause mortality; stroke; single leaflet device attachment; device embolization; endocarditis requiring surgery; Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery; heart failure (HF) related hospitalization; New York Heart Association (NYHA) classification; 6-Minute Walk Distance (6MWD) through 2 years; Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 2 years; 36-Item Short Form Survey (SF-36) score through 2 years; mitral valve surgery (including type of surgery); new use of Cardiac Resynchronization Therapy (CRT); new use of single or dual chamber pacemaker; permanent left ventricular assist device (LVAD) implant; heart transplant; additional MitraClip device intervention or de novo MitraClip device intervention; including reason for intervention; number of hospitalizations and reason for hospitalization (i.e.; heart failure; cardiovascular; non-cardiovascular) through 2 years; number of days alive and out of hospital; number of days hospitalized; proportion of subjects living in the baseline location; new onset of permanent atrial fibrillation; mitral stenosis; clinically significant atrial septal defect (ASD) that requires intervention; and dosages of guideline directed medical therapy (GDMT).

5 years

P100009 S028 / PAS002

ABBOTT VASCULAR INC.

MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System

Cardiovascular

2019-03-14

Registry-Based CAP Cohort and RWU Surveillances

2019-07-26

Progress Adequate

Comprehensive/Linked/RegistryBased Surveillance

False

External Registry

Historical Control

Descriptive

Adult: >21

Comprehensive/linked/registry-based surveillances. The objectives of the surveillances are to characterize the clinical outcomes of the continued access protocol (CAP) cohort annually through 5 years post-procedure and to assess the real-world use of the commercial MitraClip System to ensure that the device is used in appropriate circumstances.

Patients with symptomatic; moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR greater than or equal to Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) greater than or equal to 20% and less than or equal to 50%; and a left ventricular end systolic dimension (LVESD) less than or equal to 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

All living CAP subjects who were enrolled at participating institutions and a total of 5000 consecutively treated patients at a minimum of 100 representative institutions across the United States.

The clinical data through one (1) year will be collected through the TVT Registry. The follow-up data (including all-cause mortality; stroke; repeat procedure for mitral valve-related dysfunction; and hospitalization) from year 2 through year 5 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.

5 years

P100009/ PAS002

ABBOTT VASCULAR INC.

MITRACLIP DELIVERY SYSTEM

Cardiovascular

2013-10-24

New EnrollMitraClip Analysis Cohort (MAC)

2013-10-24

2016-04-05

Completed

Prospective Cohort Study

False

External Registry

Objective Performance Criterion

Analytical

Adult: >21

A prospective cohort study; a subset of patients entered into the MitraClip TVT-Registry who fulfill the enrollment criteria and from sites/centers of excellence and experienced with performing and collecting 6MWT data and KCCQ data (i.e. sites/centers with at least 75% completion rate in terms of collecting both 6MWT and KCCQ data) will be included in MAC.This is a new-enrollment study.NOTE: Annual follow up (e.g. death; stroke; surgical intervention; hospitalizations) from year 2 through year 5 post-implant through linkage to the CMS database will be reported as part of P100009/PAS001- OSB-lead Comprehensive/Linked-Registry Based Surveillance. <A HREF="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=444395&c_id=1705">PAS1</A>

A subset of approximately 420 patients entered into the MitraClip TVT-Registry who fulfill the following criteria in MAC: Significant symptomatic MR (? 3+) due to primary abnormality of the mitral apparatus; otherwise known as Degenerative Mitral Regurgitation (DMR). Prohibitive risk for mitral valve surgery (MV) as determined by a heart team; which includes a cardiologist experienced in MV disease and a cardiac surgeon experienced in MV surgery; and existing comorbidities that would not preclude the expected benefit from reduction of the MR. Perform the 6MWT at baseline or unable to perform the 6MWT due to cardiac reasons.No comparator group.

Assuming 10% withdrawal at 12 months; a sample size of 420patients from the Prohibitive Risk DMR Patient Registry (PAS 1Device Registry) is expected to provide 420 evaluable patients (notlost-to-follow-up or discontinued) at 12 months post procedure.Assumptions: The reported death rate at 30 days was 6.3% in the Prohibitive Risk DMR Cohort (Lim et al 2013); the all-cause mortality rate at 30 days was assumed to be 6.5%. The device- related complication rate was assumed to be ~6% at 12 months.Because a majority of device-related complications are expected to occur within 30 days of the MitraClip procedure; the rate at 30days was also assumed to be ~6%. Two thousand (2;000) simulations were performed to calculate sample size and power for the primary safety endpoint. A sample size of 420 evaluable patients provides >95% power to reject the null hypothesis at the5% significance level.Two thousand (2;000) simulations were performed to calculate sample size and power for the primary effectiveness endpoint. Assuming 37% attrition (25% death; 10% withdrawal; and 2% missing data) at 12 months; a sample size of 420 evaluable patients provides >95% power to reject the null hypothesis at the 5% significance level.There will be a minimum of 15 sites and a maximum of 40 sites; with no more than 10% of patients (up to 46) from each site. Sites selected for participation in this study will be centers of excellence and experienced with performing and collecting 6MWT data and KCCQ data.

Main safety endpoints:A composite of death and device-related complications at 30 dayspost-procedure. The device-related complications include single leaflet device attachment (SLDA); device embolization; device thrombosis; and other device-related events (e.g.; endocarditis; MV stenosis); which result in MV re-intervention; unplanned other cardiac surgery; or unplanned vascular surgery or intervention through 30 days post-procedure.Secondary safety endpoints:All-cause mortality at 12 months; and device-related complications at 12 months.Main effectiveness endpoints:The change in 6MWT distance at 12 months over baseline.Secondary effectiveness endpoints: MR severity at 12 months Change in LVEDV at 12 months over baseline Change in LVIDd at 12 months over baseline Change in KCCQ QoL at 12 months over baselineNYHA Functional Class at 12 Months

5 yearsActive follow-up of patients will be performed through 12 months

A total 554 study subjects who entered into STS/ACC Transcatheter Valve Therapy (TVT) registry between November 04; 2013 and July 29; 2015 and met eligibility criteria for this study were enrolled in this post-approval study.

A total of 50 sites (sites with at least 75% data completeness of both baseline 6-minute walking test and KCCQ data) were included in this post-approval study.

The overall follow-up rate at 1-year through the Mitral Module of the TVT registry is 78.2%.

The primary safety endpoint of rate of freedom from composite of death and device-related complications at 30 days was 95.5% (529/554); which was significantly higher than the pre-specified performance goal of 80% (P<0.0001). For secondary safety endpoints; freedom from all-cause mortality at 12 months was 80.2% (SE: 1.85%; performance goal=66%; P<0.0001); and freedom from the composite device-related complications at 12 months was 98.9% (SE: 0.45%; performance goal=90%; P<0.0001). All primary and secondary safety endpoints were successfully met.

The primary effectiveness endpoint of mean improvement in 6-minute walking test (6MWT) at 12 months from baseline was 31.56Â±115.24 meters. The results showed significantly improvement at 12 months (one-sided p-value=0.0001). Analysis of secondary effectiveness endpoints shows significant mitral regurgitation (MR) reduction (P<0.0001) and improvement in NYHA class (P<0.0001) at 12-months from baseline; reduction in left ventricular size at 12-months from baseline as per LVEDV (-10.9 Â± 48.9 ml; P=0.0111) and LVIDd (-0.22Â±0.72 cm; P<0.0001) measurements as well as improvement of Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months over baseline (30.40Â±25.77; P<0.0001).

Strength: This study was able to demonstrate the safety and effectiveness of Mitral Valve Repair and Clip Delivery Systems (MitraClipÂ®) using real-world data collected through the national STS/ACC TVT Registry.Weakness: Sample size for some of the subgroup analyses; such as recurrent mitral regurgitationsubgroup; was relatively small; resulting in large standard deviations for the estimates. Although primary effectiveness endpoint was successfully met; only about 62.1% patients among those who have completed 12-month visit had 6MWT information available (including patients who performed 6MWT or were unable to perform due to cardiac reasons). High proportion of missing values were also reported for LVEDV endpoint at 12 months (36.8% of patients who completed 12-month have information available). Patients included in this study were enrolled from sites with at least 75% completion rate in terms of collecting both baseline 6MWT and KCCQ data; and results may not be generalizable to patients enrolled from sites with less experience performing and collecting 6MWT and KCCQ data.Finally; the data available are limited to 1-year follow-up currently; additional data on longer term (5- year) safety and effectiveness remain to be assessed.

Yes; labeling change recommended to update the device labeling with the final study results.

P100009/ PAS001

ABBOTT VASCULAR INC.

MITRACLIP DELIVERY SYSTEM

Cardiovascular

2013-10-24

Comprehensive/Linked-Registry Based Surv

2013-10-24

2014-06-13

Progress Adequate

Comprehensive/Linked/RegistryBased Surveillance

False

External Registry

Concurrent Control

Descriptive

Adult: >21

Objectives: to assess long term safety and effectiveness of theMitraClip device in a broad patient population and to study howprohibitive risk is interpreted in real-world use of the MitraClip device to ensure the device is used in appropriate circumstances.Study design: a prospective; single-arm; multi-center; observational study of a minimum of 2;000 MitraClip patients consecutively entered into the TVT Registry. A new enrollment study.

Patients who have been determined to be at prohibitive risk formitral valve surgery by a heart team; and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation; patients treated in accordance with the MitraClip Clip Delivery System labeling; formal protocol- specific inclusion and exclusion criteria will not be used.Cohort A: Patients treated per the MitraClip Clip Delivery System indication approved on October 24; 2013 will comprise Cohort A. Patients will be identified as Cohort A for analyses if the data collected on the eCRFs identify symptomatic DMR ≥3+ and at leastone reason for prohibitive risk.Cohort B: patients from the PAS 1 Device Registry who are not included in Cohort A.

Subjects: 2;000 MitraClip patients consecutively entered into the TVT Registry.Sites: This study will include all sites participating in the STS/ACCF TVT Registry and trained by Abbott Vascular to implant the MitraClip device.A minimum of 2;000 patients will allow detection of low frequency safety events and provide improved precision for the rates of safety events that have previously been characterized.

Primary Safety/Effectiveness Endpoints:The following endpoints will be reported through 1 year follow-upfrom data extracted from the TVT-R:Â¿ All-cause mortality at 30 days and 1 yearÂ¿ Stroke at 30 days and 1 yearÂ¿ NYHA Functional Class at 30 days and 1 yearÂ¿ Hospitalizations (All-cause and HF-related) at 1 yearÂ¿ The echo parameters of MR severity; left ventricular end-diastolic volume (LVEDV) and Left Ventricular Internal Dimension-Diastole (LVIDd) at baseline; 30 days and 1 year in all patients and in the subset of patients who undergo mitral valve (MV) surgery within the first yearThe following endpoints will be reported for years 2 - 5 post-implant by linking data extracted from the TVT Registry to the Center for Medicare and Medicaid Services (CMS) Claims database:Â¿ All-cause mortalityÂ¿ StrokeÂ¿ Hospitalizations (All-cause and HF-related)Â¿ Surgical interventionsSecondary Safety/Effectiveness Endpoints:Interpretation of the definition of prohibitive risk status incommercial use will also be reported on. Prohibitive risk status willbe audited by a qualified MitraClip Registry Audit Committee Charter (MRAC) that meets quarterly. The composition and the schedule for auditing is described in the MRAC Charter document (received on June 10; 2014).

5 yearsDischarge; 30 days; 1 year annually through 5 years