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

Sponsor

NeoChord (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04190602

Collaborator

(none)

500

Enrollment

Locations

93.7

Anticipated Duration (Months)

100

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation Mitral Valve Disease Mitral Valve Insufficiency Mitral Valve Prolapse Heart Valve Diseases	Device: NeoChord Artificial Chordae Delivery System, Model DS1000

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

Actual Study Start Date :

Feb 9, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

Level of Mitral Regurgitation Following the Index Procedure [Completion of Index Procedure]
Level of mitral regurgitation per echocardiography

Secondary Outcome Measures

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
Level of Mitral Regurgitation at 3 Years [3 Years]
Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 4 Years [4 Years]
Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 5 Years [5 Years]
Level of mitral regurgitation per echocardiography

Other Outcome Measures

Freedom from Mitral Valve Re-intervention [From enrollment until date of mitral valve reintervention, up to 5 years]
Freedom from All-Cause Mortality [From enrollment until date of death, up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	University of Bonn	Bonn	Germany
2	CVC Frankfurt	Frankfurt	Germany
3	University of Mainz	Mainz	Germany
4	Hippokration Hospital	Athens	Greece
5	Triemli Hospital	Zurich	Switzerland