CASSINI-US
Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
AI Description
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
- adult, older adult
- Participants
- 15
- Expected completion
- 2032-09
- Funded by
- industry
Conditions studied
Heart Disease, Mitral Regurgitation
What is being tested
- DEVICE: Mitral Valve Replacement
What it measures
- Freedom from Major Adverse Events Endpoint, Freedom from (n/N, %) device-related or procedure-related major adverse events (MAE) which include: Cardiovascular death, Peri-procedural myocardial infarction, Disabling stroke, Major cardiac structural complication, Major vascular complication, and Mitral reintervention (operative or transcatheter) due to progressive or recurrent MR or device-related complications., 30 days from index procedure
- Mitral Valve Effectiveness Endpoint (reduction in MR grade), Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days., 30 days post treatment
- Technical (Implant) Success Endpoint, Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol., At completion of study procedure (Day 0)
Working with
Avania
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-08-10
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.