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Clinical Trials in the USA / NCT02803957
Active, not recruiting Not applicable

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

NCT02803957 · tracked via the Priya Life Science USA tracker
Sponsor
NeoChord
Phase
Not applicable
Started
2016-11-03
Last updated
2026-04-08

Condition(s) studied

Mitral Valve Insufficiency

Investigational drug(s) / intervention(s)

NeoChord DS1000Surgical Mitral Valve Repair

NeoChord DS1000: Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000

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.

Study summary

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).

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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
  • 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

Trial sites (14)

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

Other trials for the same condition

The ENCIRCLE Trial Active, not recruiting
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR Recruiting
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study Recruiting
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System Active, not recruiting
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02803957 on ClinicalTrials.gov ↗ ← All trials in the USA