Observational Registry on the HARPOON Device (REPLICATE)

January 9, 2024 updated by: Edwards Lifesciences

Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89070
        • Universitätsklinik Ulm
    • Bayern
      • Bad Neustadt, Bayern, Germany, 97616
        • Rhön Klinikum Kardiochirurgie
      • Passau, Bayern, Germany, 94032
        • Klinikum Passau
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • Universitätsmedizin Göttingen
    • Nordrhein-Westfalen
      • Wuppertal, Nordrhein-Westfalen, Germany, 42283
        • Helios Universitätsklinikum Wuppertal
  • Spain
    • Illes Balears
      • Palma, Illes Balears, Spain, 07010
        • Hospital Son Espases
  • Switzerland
      • Bern, Switzerland, 3010
        • Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HARPOON™ MVRS
Subjects who were treated with the HARPOON MVRS.
Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Repair of the chordae tendinae in the mitral valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant
Time Frame: 1 year post-implant
Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant
1 year post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Collaborators

ICON plc

Investigators

  • Principal Investigator: Thomas Walther, Prof Dr med, Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Actual)

November 17, 2022

Study Completion (Actual)

November 17, 2022

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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