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Follow-up on the safety and effectiveness of the Edwards PASCAL Valve Repair System

Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)

Observational Edwards Lifesciences · NCT04430075

This study is testing how safe and effective the Edwards PASCAL Valve Repair System is for people getting treatment for mitral valve problems, and how it affects their health and quality of life afterward.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations37 sites (Vienna and 36 other locations)
Trial IDNCT04430075 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in patients undergoing transcatheter mitral valve repair. The study will assess improvements in mitral regurgitation, functional status, and quality of life in a post-market setting. Participants will be monitored through follow-up visits to evaluate the outcomes of the valve repair systems.

Who should consider this trial

Good fit: Ideal candidates include patients with mitral regurgitation who are eligible for transcatheter edge-to-edge repair after a Heart Team discussion.

Not a fit: Patients requiring non-elective or emergency procedures, or those in the ICU prior to the procedure, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of transcatheter mitral valve repair, potentially leading to improved patient outcomes.

How similar studies have performed: Other studies on transcatheter mitral valve repair have shown promising results, indicating that this approach is supported by prior successful outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
2. Patient is willing and able to attend all follow-up visits and to perform all tests
3. Provision of written informed consent

Exclusion Criteria:

1. Patients are not eligible per the current Instructions for Use
2. Non-elective or emergency TEER procedure for mitral regurgitation
3. Patients in ICU prior to the index procedure

Where this trial is running

Vienna and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral RegurgitationMitral Insufficiency
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.