ClinicaliQ Trial Snapshot
- Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT06414265.
- Sponsor: InnovHeart.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are: * is the use of the device feasible? * is it safe (defined as freedom from device-related major adverse events at 30 days)? * does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)? Participants will need to do the following as part of…
Eligibility Snapshot
- : 1. Age 65 years or older. 2. Symptomatic moderate to severe or severe functional mitral regurgitation (≥ Grade 3+). 3. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory. 4. Ability to tolerate oral anticoagulation. 5. Ability to qualify for bailout surgery (which may include open heart surgery). 6. High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team. 7. Willing and able to complete study-related assessments and questionnaires.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.