Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Running, not enrolling · Not applicable

Conditions studied: Mitral Valve Insufficiency

In brief

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).

Key facts

Study ID

NCT02803957

Run by

NeoChord

People needed

585

Starts

2016-11-03

Expected to finish

2027-01-01

Last updated by the study team

2026-04-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Mercy General Hospital — Sacramento, California, United States
• Stanford University — Stanford, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Franciscan Health — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mount Sinai, Icahn School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Pinnacle Health — Harrisburg, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• St. Thomas — Nashville, Tennessee, United States
• Baylor - Plano — Plano, Texas, United States
• Valley Health System | Virginia — Winchester, Virginia, United States

Full record on ClinicalTrials.gov

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