Observational Registry on the HARPOON Device

Not Applicable

Terminated

• Conditions: Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
• Interventions: Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)

• Registration Number: NCT04393779
• Lead Sponsor: Edwards Lifesciences

Brief 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.

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 Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2020-10-02
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-17
• Results First Submitted: 2023-12-07
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Results First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HARPOON™ MVRS	HARPOON Beating Heart Mitral Valve Repair System (MVRS)	Subjects who were treated with the HARPOON MVRS.

Primary Outcome Measures

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

Trial Locations

Locations (7)

Hospital Son Espases; 🇪🇸 Palma, Illes Balears, Spain

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Niedersachsen, Germany

Rhön Klinikum Kardiochirurgie; 🇩🇪 Bad Neustadt, Bayern, Germany

Universitätsklinik Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Klinikum Passau; 🇩🇪 Passau, Bayern, Germany

Helios Universitätsklinikum Wuppertal; 🇩🇪 Wuppertal, Nordrhein-Westfalen, Germany

Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern; 🇨🇭 Bern, Switzerland