Observational Registry on the HARPOON Device

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

— REPLICATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04393779
• Other study ID #: 2019-12
• Status: Terminated
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: November 17, 2022

Study information

• Verified date: January 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Repair of the chordae tendinae in the mitral valve.

Locations

Country	Name	City	State
Germany	Rhön Klinikum Kardiochirurgie	Bad Neustadt	Bayern
Germany	Universitätsmedizin Göttingen	Göttingen	Niedersachsen
Germany	Klinikum Passau	Passau	Bayern
Germany	Universitätsklinik Ulm	Ulm	Baden-Württemberg
Germany	Helios Universitätsklinikum Wuppertal	Wuppertal	Nordrhein-Westfalen
Spain	Hospital Son Espases	Palma	Illes Balears
Switzerland	Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Edwards Lifesciences	ICON plc

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 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