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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Comprehensive/Linked-Registry Based Surv


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General
Application Number P100009 / PAS001
Current Plan Approved 06/13/2014
Study Name OSB Lead-Comprehensive/Linked-Registry Based Surv
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objectives: to assess long term safety and effectiveness of the

MitraClip device in a broad patient population and to study how

prohibitive 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.

Study Population Description Patients who have been determined to be at prohibitive risk for

mitral 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 least

one reason for prohibitive risk.



Cohort B: patients from the PAS 1 Device Registry who are not included in Cohort A.

Sample Size 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.

Data Collection Primary Safety/Effectiveness Endpoints:

The following endpoints will be reported through 1 year follow-up

from data extracted from the TVT-R:

¿ All-cause mortality at 30 days and 1 year

¿ Stroke at 30 days and 1 year

¿ NYHA Functional Class at 30 days and 1 year

¿ Hospitalizations (All-cause and HF-related) at 1 year

¿ 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 year



The 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:

¿ All-cause mortality

¿ Stroke

¿ Hospitalizations (All-cause and HF-related)

¿ Surgical interventions

Secondary Safety/Effectiveness Endpoints:

Interpretation of the definition of prohibitive risk status in

commercial use will also be reported on. Prohibitive risk status will

be 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).

Follow-up Visits and Length of Follow-up 5 years

Discharge, 30 days, 1 year annually through 5 years


OSB Lead-Comprehensive/Linked-Registry Based Surv Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report and 12 month report 04/24/2014 01/16/2015 Overdue/Received
18 month report 04/24/2015 04/24/2015 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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