MedTrace Logo

Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.

NCT04382612 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-12-22

Study results available
· View outcomes & findings →

Summary

To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Repair of the chordae tendinae in the mitral valve.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Thomas Walther, Prof Dr med · Goethe University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2022-11-14
Completion
2022-12-01
FDA Device
Yes

Countries

  • Austria
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

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 NCT04382612 on ClinicalTrials.gov