Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (NCT02803957)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (4 items).
Location: Mercy General Hospital — Sacramento, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior mitral valve surgery
- Concomitant cardiac procedures
- Other cardiac procedures within 3 months
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (14 Sites)
- 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
💰 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 § 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.