Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Purpose

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).

Condition

  • Mitral Valve Insufficiency

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Sutter Health/Alta Bates Summitt Medical Center
Oakland, California 94609

Mercy General Hospital
Sacramento, California 95819

Stanford University
Stanford, California 94305

MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010

Piedmont Heart Institute
Atlanta, Georgia 30339

Franciscan Health
Indianapolis, Indiana 46237

Johns Hopkins University
Baltimore, Maryland 21287

University of Michigan
Ann Arbor, Michigan 48109

Mount Sinai, Icahn School of Medicine
New York, New York 10029

Columbia University Medical Center
New York, New York 10032

Pinnacle Health
Harrisburg, Pennsylvania 17110

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232

St. Thomas
Nashville, Tennessee 37205

Baylor - Plano
Plano, Texas 75093

Valley Health System | Virginia
Winchester, Virginia 22601

More Details

Status
Recruiting
Sponsor
NeoChord

Study Contact

David H Adams, MD
212-659-6820
david.adams@mountsinai.org