πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-02

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (NCT02803957)

Randomized Trial of the NeoChordβ„’ DS1000β„’ System Versus Open Surgical Repair

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: NeoChord

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Mercy General Hospital β€” Sacramento, California

Age range: 21 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (14 Sites)

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

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—