Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

Recruiting

• Conditions: Heart Valve Diseases; Mitral Regurgitation; Mitral Valve Disease; Mitral Valve Insufficiency; Mitral Valve Prolapse

• Registration Number: NCT04190602
• Lead Sponsor: NeoChord

Brief Summary

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Detailed Description

This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Study Start: 2020-02-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10
• Primary Completion: 2022-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
• Study procedure completed after 31 December 2016

Exclusion Criteria

• Heavily calcified valves
• Valvular retraction with severely reduced mobility
• Active bacterial endocarditis
• Complex mechanism of MR (leaflet perforation, etc.)
• Significant tethering of leaflets
• Inflammatory valve disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of Mitral Regurgitation Following the Index Procedure	Completion of Index Procedure	Level of mitral regurgitation per echocardiography

Secondary Outcome Measures

Name	Time	Method
Level of Mitral Regurgitation at 4 Years	4 Years	Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 3 Years	3 Years	Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 5 Years	5 Years	Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 3-6 Months	3-6 Months	Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 1 Year	1 Year	Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 2 Years	2 Years	Level of mitral regurgitation per echocardiography

Trial Locations

Locations (5)

University of Bonn; 🇩🇪 Bonn, Germany

Triemli Hospital; 🇨🇭 Zurich, Switzerland

CVC Frankfurt; 🇩🇪 Frankfurt, Germany

University of Mainz; 🇩🇪 Mainz, Germany

Hippokration Hospital; 🇬🇷 Athens, Greece