RECRUITING

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair

Quick Facts

Study Start:2016-11-03
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02803957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is a candidate for mitral valve repair with cardiopulmonary bypass
  2. * Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
  3. * 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
  4. * Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
  5. * Anatomic and general suitability
  1. * Prior mitral valve surgery
  2. * Concomitant cardiac procedures
  3. * Other cardiac procedures within 3 months

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Sutter Health/Alta Bates Summitt Medical Center
Oakland, California, 94609
United States
Mercy General Hospital
Sacramento, California, 95819
United States
Stanford University
Stanford, California, 94305
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Florida Hospital
Orlando, Florida, 32803
United States
Piedmont Heart Institute
Atlanta, Georgia, 30339
United States
Franciscan Health
Indianapolis, Indiana, 46237
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mount Sinai, Icahn School of Medicine
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
Pinnacle Health
Harrisburg, Pennsylvania, 17110
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
St. Thomas
Nashville, Tennessee, 37205
United States
Baylor - Plano
Plano, Texas, 75093
United States
Valley Health System | Virginia
Winchester, Virginia, 22601
United States

Collaborators and Investigators

Sponsor: NeoChord

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11-03
Study Completion Date2027-07

Study Record Updates

Study Start Date2016-11-03
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Degenerative
  • Mitral Regurgitation

Additional Relevant MeSH Terms

  • Mitral Valve Insufficiency