Reduction of Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovHeart
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mitral Valve Replacement
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
InnovHeart
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov