Condition: Heart Failure · Sponsor: InnovHeart
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 the clinical trial: * complete 6-Minute Walking Test * complete Quality of Life Questionnaires * undergo blood evaluations * CT scan * 12 lead ECG * Transesophageal Echocardiography * Transthoracic Echocardiogram * the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)
This description comes directly from the study's public registry record.
VP, Clinical Affairs InnovHeart · +49 69 24003626 · a.roach@innovheart.com
Maxis Operations · maxisoperations@maxismedical.com
Always discuss trial participation with your own doctor first.
| Tbilisi Heart and Vascular Clinic | Tbilisi, Georgia | Recruiting |
| Tbilisi Heart Center | Tbilisi, Georgia | Recruiting |
| Ospedale San Raffaele | Milan, Italy | Recruiting |
| Instituto Clinico Humanitas | Milan, Italy | Recruiting |
| Vilnius University Hospital Santaros Klinikos | Vilnius, Lithuania | Recruiting |
| Górnośląskie Centrum Medyczne | Katowice, Poland | Recruiting |
| Warsaw Medical University | Warsaw, Poland | Recruiting |
| Royal Sussex County Hospital | Brighton, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06414265