ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02803957
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
NeoChord

Brief 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).

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: NeoChord DS1000 Device: Surgical Mitral Valve Repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Actual Study Start Date : November 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2025

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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is a candidate for mitral valve repair with cardiopulmonary bypass
  • Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation per baseline Echo Core Lab assessment
  • Isolated segmental prolapse of the A2 or P2 segment
  • Anterior leaflet covers at least 65% of anterior-posterior annular distance
  • Anatomic and general suitability

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803957


Contacts
Contact: David H Adams, MD 212-659-6820 david.adams@mountsinai.org
Contact: Michael Borger, MD, Ph.D. +49-341-865-1421 Michael.Borger@helios-kliniken.de

Locations
United States, California
Sutter Health/Alta Bates Summitt Medical Center Recruiting
Oakland, California, United States, 94609
Principal Investigator: Junaid Khan, MD         
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Principal Investigator: Frank Slachman, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Principal Investigator: Jack Boyd, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Vinod Thourani, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: Kevin Accola, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30339
Principal Investigator: Frederico Milla, MD         
United States, Indiana
Franciscan Health Recruiting
Indianapolis, Indiana, United States, 46237
Principal Investigator: Marc Gerdisch, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Kenton Zehr, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Matthew Romano, MD         
United States, New York
Mount Sinai, Icahn School of Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: David H Adams, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Isaac George, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Mario Castillo-Sang, MD         
United States, Pennsylvania
Pinnacle Health Recruiting
Harrisburg, Pennsylvania, United States, 17110
Principal Investigator: Mubashir Mumtaz, MD         
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: John Conte, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Thomas Gleason, MD         
United States, Tennessee
St. Thomas Recruiting
Nashville, Tennessee, United States, 37205
Principal Investigator: Evelio Rodriguez, MD         
United States, Texas
Baylor - Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: Robert Smith, MD         
United States, Virginia
Valley Health System | Virginia Recruiting
Winchester, Virginia, United States, 22601
Principal Investigator: Basel Ramlawi, MD         
Sponsors and Collaborators
NeoChord

Responsible Party: NeoChord
ClinicalTrials.gov Identifier: NCT02803957     History of Changes
Other Study ID Numbers: NeoChord: PR-610405-100
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NeoChord:
Degenerative
Mitral Regurgitation

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases