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The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

NCT03170349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-02-05

Study results available
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Summary

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

Mitral Valve Repair

Minimal Invasive Transcatheter Mitral Valve Repair

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Gideon Cohen, MD · Sunnybrook Hospital

  • Ulrich Schafer, MD · BundeswehrZentralkrankenhaus Koblenz

  • Molly Szerlip, MD · The Heart Hospital Baylor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2020-07-30
Completion
2025-05-27
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Greece
  • Italy
  • 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 NCT03170349 on ClinicalTrials.gov