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NCT04190602 | RECRUITING | Mitral Regurgitation


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

Condition or disease

Mitral Regurgitation

Mitral Valve Disease

Mitral Valve Insufficiency

Mitral Valve Prolapse

Heart Valve Diseases

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Actual Study Start Date : 2020-02-09
Estimated Primary Completion Date : 2022-10
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT04190602


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Germany,

University of Bonn

Bonn, Germany,

RECRUITING

Germany,

CVC Frankfurt

Frankfurt, Germany,

RECRUITING

Germany,

University of Mainz

Mainz, Germany,

RECRUITING

Greece,

Hippokration Hospital

Athens, Greece,

RECRUITING

Switzerland,

Triemli Hospital

Zurich, Switzerland,

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