Post-Approval Studies (PAS) Database

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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Registry-Based Real-World Use Surveillance

General
Study Status	Ongoing
Application Number / Requirement Number	P220003 / PAS002
Date Original Protocol Accepted	09/14/2022
Date Current Protocol Accepted
Study Name	Registry-Based Real-World Use Surveillance
Device Name	PASCAL Precision Transcatheter Valve Repair System
Clinical Trial Number(s)	NCT03706833
General Study Protocol Parameters
Study Design	Active Surveillance
Data Source	External Registry
Comparison Group	Historical Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to assess the real-world performance of the PASCAL Precision system.
Study Population	The surveillance will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
Sample Size	All consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
Key Study Endpoints	The clinical data through one (1) year are 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 are obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.
Follow-up Visits and Length of Follow-up	5 years
Interim or Final Data Summary
Interim Results	Safety Results: Device implanted successfully: 97.5% At 30 Days: All-cause death: 2.0% All stroke: 1.2% Mitral valve re-intervention: 0.3% All-cause hospitalization: 9.1% Heart failure hospitalization: 2.6% Single leaflet device attachment: 0.5% Major or life-threatening bleed: 1.7% At 1 Year: All-cause death: 6.1% All stroke: 1.6% Mitral valve re-intervention: 1.6% All-cause hospitalization: 18.9% Heart failure hospitalization: 6.2% Effectiveness Results: Mitral Regurgitation (Greater than Moderate-Severe): 100% (Baseline); 7.0% (30 Days) KCCQ (Overall Score): Change from baseline to 30-day visit: 20.8 Change from baseline to 1-year visit: 22.1 NYHA Class: Improved or stayed the same at 30-day visit: 96.7% Improved or stayed the same at 1-year visit: 94.7%
Actual Number of Patients Enrolled	1402 patients
Actual Number of Sites Enrolled	145 sites
Patient Follow-up Rate	Patient status known: 91.8%

Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	09/14/2023	07/03/2024	Overdue/Received
2 year report	09/13/2024	09/10/2024	On Time
3 year report	09/13/2025
4 year report	09/13/2026
5 year report	09/13/2027

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background