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

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)

Facility	City	Region
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

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve Active, not recruiting

PARTNER 3 Trial - Mitral Valve in Valve Active, not recruiting

The ENCIRCLE Trial Recruiting

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System Active, not recruiting

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study 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