Clinical Trial

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

Study acronym: CASSINI-US
Recruiting
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Summary
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-11
notable Primary completion pushed: 2027-01 -> 2027-09 2026-08-11
minor Completion pushed: 2032-01 -> 2032-09 2026-08-11
Trial Details
NCT Number NCT07130994
Lead Sponsor InnovHeart
Collaborators: Avania
Conditions Mitral Regurgitation, Heart Disease
Enrollment 15 participants
Start Date 2026-08-05
Primary Completion 2027-09 (estimated)
Study Completion 2032-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-10