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Observational Registry on the HARPOON Device

NCT04393779 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-01-29

Study results available
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Summary

To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

Conditions

  • Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse

Interventions

DEVICE

HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Repair of the chordae tendinae in the mitral valve.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • 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
2022-11-17
Completion
2022-11-17
FDA Device
Yes

Countries

  • Germany
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

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 NCT04393779 on ClinicalTrials.gov