NCT04443218

Edwards PASCAL Transcatheter Valve Repair System Registry

Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.

Detailed description

Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.

Conditions

• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Edwards PASCAL Transcatheter Valve Repair System	The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.

Timeline

• Start date: 2019-05-27
• Primary completion: 2021-05-10
• Completion: 2021-05-10
• First posted: 2020-06-23
• Last updated: 2024-07-26
• Results posted: 2024-07-26

Locations

14 sites across 2 countries: Germany, Switzerland