Active, not recruitingNCT02803957

ReChord

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

NeoChordMultiple US sitesView on ClinicalTrials.gov

AI Description

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

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Who can join
adult, older adult
Participants
585
Expected completion
2027-01
Funded by
industry

Conditions studied

Mitral Valve Insufficiency

What is being tested

  • DEVICE: NeoChord DS1000
  • DEVICE: Surgical Mitral Valve Repair

What it measures

  • Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group., 1 year
  • Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group., Post-operative Day (POD) 30

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2026-04-08

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

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