Edwards PASCAL Transcatheter Valve Repair System Registry (PASCALRegistry)

Edwards Lifesciences

Status: Completed

Conditions: Mitral Valve Insufficiency

Treatments: Device: Edwards PASCAL Transcatheter Valve Repair System

Study type: Observational

Funder types: Industry

Identifiers

NCT04443218

2019-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient signs informed consent to participate in the registry
• Patient is intended to or has received the PASCAL device

Exclusion criteria

• Patient does not consent to participate
• Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.

Trial design