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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

NCT03706833 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1247

Last updated 2026-04-09

No results posted yet for this study

Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Conditions

  • Degenerative Mitral Valve Disease
  • Mitral Regurgitation
  • Mitral Insufficiency
  • Functional Mitral Regurgitation

Interventions

DEVICE

Edwards PASCAL System

Transcatheter mitral valve repair with the Edwards PASCAL System

DEVICE

Abbott Mitraclip System

Transcatheter mitral valve repair with the Abbott Mitraclip System

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Scott Lim, MD · University of Virginia

  • Robert Smith, MD · The Heart Hospital Baylor Plano

  • Linda Gillam, MD · Morristown Medical Center

  • Vinod Thourani, MD · Piedmont Healthcare

  • Paul Grayburn, MD · The Heart Hospital Baylor Plano

  • Brian K Whisenant, MD · Intermountain Medical Center

  • Jörg Hausleiter, MD · LMU München, Campus Gorsshadern

  • Ralph Stephan von Bardeleben, MD · / Universitätsmedizin Mainz- Zentrum für Kardiologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2026-06-30
Completion
2031-06-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03706833 on ClinicalTrials.gov