πŸ›οΈ Verified NIH Record β€’ Updated 2026-08-06

Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US) (NCT07130994)

Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-septal TMVR System in Patients With Severe, Symptomatic Mitral Regurgitation (Cassini-US)

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: InnovHeart

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

CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US). The purpose of the study is to evaluate the technical (implant) feasibility, and safety, and performance of the SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. Primary objectives evaluate the implant feasibility, and acute safety and performance of the SATURN TS TMVR System. The secondary objective and additional outcome measures characterize the long-term safety and performance of the SATURN TS TMVR System.

Who can join: Review the eligibility criteria below.

Location: Cedars-Sinai Medical Center β€” Los Angeles, California

Age range: 18 Years

πŸ§ͺ Interventions in This Study

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 (5 Sites)

  • Cedars-Sinai Medical Center β€” Los Angeles, California
  • UC Davis Health β€” Sacramento, California
  • Los Robles Regional Medical Center β€” Thousand Oaks, California
  • Columbia University Irving Medical Center/New York Presbyterian Hospital β€” New York, New York
  • Oregon Health & Science University β€” Portland, Oregon

πŸ“ž Contact the Study Coordinator

Phone: +39 0125538873

Email: a.roach@innovheart.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†—