Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: InnovHeart
You may qualify if…
- ✓ Age 18 years or older.
- ✓ Symptomatic, moderate to severe or severe, functional or mixed, mitral regurgitation (≥ Grade 3+).
- ✓ NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- ✓ Ability to tolerate oral anticoagulation.
- ✓ Ability to qualify for bailout surgery (which may include open heart surgery).
- ✓ High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team.
- ✓ Willing and able to complete study-related assessments and questionnaires.
You may not qualify if…
- ✕ Purely degenerative (organic/primary) (i.e. intrinsic valve lesions) mitral regurgitation.
- ✕ Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement.
- ✕ Life expectancy \<1 yr. due to noncardiac conditions.
- ✕ Endocarditis in the 3 months prior to procedure date.
- ✕ Current admission with acute heart failure exacerbation.
- ✕ Dependency on inotropic agents or mechanical circulatory support.
- ✕ Untreated clinically significant CAD.
- ✕ Active systemic infection.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07130994 · last updated 2026-08-10