Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (ReChord)

April 2, 2026 updated by: NeoChord

Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

585

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Stanford, California, United States, 94305
        • Stanford University
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Piedmont Heart Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai, Icahn School of Medicine
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • St. Thomas
    • Texas
      • Plano, Texas, United States, 75093
        • Baylor - Plano
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Valley Health System | Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is a candidate for mitral valve repair with cardiopulmonary bypass
  • Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
  • Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
  • Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
  • Anatomic and general suitability

Exclusion Criteria:

  • Prior mitral valve surgery
  • Concomitant cardiac procedures
  • Other cardiac procedures within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
Device: NeoChord DS1000
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Active Comparator: Control Group
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
Device: Surgical Mitral Valve Repair
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
Time Frame: Post-operative Day (POD) 30
Post-operative Day (POD) 30
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.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoChord

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoChord: PR-610405-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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