πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-21

A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR. (NCT07086534)

A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Sierra Valve LLC

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

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Who can join: Review the eligibility criteria below.

Location: Los Robles Regional Medical Centre β€” Thousand Oaks, California

Age range: 18 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 (1 Sites)

  • Los Robles Regional Medical Centre β€” Thousand Oaks, California

πŸ“ž Contact the Study Coordinator

Phone: (949) 539-7412

Email: Jianfong@Sierravalve.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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. Contact the study coordinator using the phone/email above.
  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†—