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

Recruiting now · Not applicable

Conditions studied: Heart Failure

In brief

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)

Key facts

Study ID

NCT06414265

Run by

InnovHeart

People needed

30

Starts

2024-04-04

Expected to finish

2030-02-01

Last updated by the study team

2026-05-20

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 65 years or older.
• Symptomatic moderate to severe or severe functional 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…

• General Exclusion Criteria
• Degenerative (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 year 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.
• Modified Rankin Scale ≥4 disability.
• Chronic renal failure defined as eGFR <30 mL/min/m2 or on renal replacement therapy.
• Severe pulmonary arterial hypertension (PAH), defined as PASP > 60mmHg.
• Platelets < 90,000.
• COPD 2 on home oxygen therapy deemed too high risk for intubation.
• Refuses blood transfusions.
• Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states).
• Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
• Participating in other investigational studies likely to confound the results or affect the study.
• Unable or does not sign the study informed consent form.
• Patients classified as "vulnerable patients" 3 .
• Cardiovascular Exclusion Criteria
• Myocardial infarction during prior 30 days.
• Stroke or TIA during prior 90 days.
• Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
• Prior mitral valve treatment (e.g., valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.

Where it is running

• Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (enrolling)
• Tbilisi Heart Center — Tbilisi, Georgia (enrolling)
• Ospedale San Raffaele — Milan, Italy (enrolling)
• Instituto Clinico Humanitas — Milan, Italy (enrolling)
• Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
• Górnośląskie Centrum Medyczne — Katowice, Poland (enrolling)
• Warsaw Medical University — Warsaw, Poland (enrolling)
• Royal Sussex County Hospital — Brighton, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.