RecruitingNot ApplicableNCT06414265

Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-Septal TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - CASSINI-EU Trial


Sponsor

InnovHeart

Enrollment

30 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the SATURN system — a minimally invasive (catheter-based) device to replace the mitral valve in the heart without open-heart surgery — in patients with severe mitral regurgitation (a "leaky" heart valve where blood flows backward). This approach goes through a vein in the leg rather than requiring open-chest surgery. **You may be eligible if...** - You are 65 or older with severe or moderate-to-severe mitral valve leakage - Your symptoms include shortness of breath or limited activity (NYHA class II or higher) - You are considered too high-risk for traditional open-heart surgery due to age, frailty, or other health conditions - You are able to take blood thinners and complete study assessments **You may NOT be eligible if...** - Your mitral regurgitation is caused by a structural defect in the valve itself (degenerative type) - You are too frail or sick even for this less invasive procedure - You have other heart conditions that make this procedure unsafe (such as certain clots or severe aortic disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscatheter mitral valve replacement

The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.


Locations(3)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Warsaw Medical University

Warsaw, Poland

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NCT06414265


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