Actively Recruiting
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
Led by InnovHeart · Updated on 2024-08-23
30
Participants Needed
3
Research Sites
304 weeks
Total Duration
On this page
Sponsors
I
InnovHeart
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older.
- Symptomatic moderate to severe or severe functional mitral regurgitation (Grade 3+ or higher).
- New York Heart Association (NYHA) functional Class II or greater; if Class IV, patient must be ambulatory.
- Ability to tolerate oral anticoagulation medication.
- Ability to qualify for bailout surgery, including open heart surgery if needed.
- Determined high risk for open-heart mitral valve surgery by a Heart Team.
- Willing and able to complete study-related assessments and questionnaires.
You will not qualify if you...
- Degenerative mitral regurgitation caused by intrinsic valve lesions.
- Excessive frailty or other health conditions that prevent expected benefit from valve replacement.
- Life expectancy less than 1 year due to non-cardiac conditions.
- Endocarditis within 3 months before the procedure.
- Current hospital admission for acute heart failure worsening.
- Dependency on inotropic drugs or mechanical circulatory support.
- Untreated significant coronary artery disease.
- Active systemic infection.
- Severe disability with Modified Rankin Scale 4 or higher.
- Chronic kidney failure with eGFR less than 30 mL/min/m2 or on dialysis.
- Severe pulmonary arterial hypertension with pulmonary artery systolic pressure over 60 mmHg.
- Platelet count below 90,000.
- COPD stage 2 on home oxygen therapy considered too high risk for intubation.
- Refusal of blood transfusions.
- Known bleeding or clotting disorders.
- Severe connective tissue disease on chronic immunosuppressive or cortisone treatment.
- Participation in other investigational studies that may affect results.
- Unable or unwilling to sign informed consent.
- Classified as vulnerable patient.
- Myocardial infarction in the past 30 days.
- Stroke or transient ischemic attack in the past 90 days.
- Severe extracardiac artery disease.
- Previous mitral valve treatments or planned mitral valve treatment before enrollment.
- Previous surgical mechanical aortic valve replacement.
- Previous transcatheter aortic valve implantation (TAVI).
- Planned cardiovascular surgery or intervention (other than mitral valve) within 30 days after procedure.
- Cardiac resynchronization therapy or implantable cardioverter defibrillator implanted in the past 30 days.
- Cardiogenic shock, unstable blood pressure below 90 mmHg, or need for inotropic or mechanical support.
- Coronary artery bypass grafting or percutaneous coronary intervention within the past 30 days.
- Inadequately treated cardiac conditions as reviewed by screening committee.
- Prior or planned heart transplantation.
- Signs of right-sided congestive heart failure such as ascites or generalized edema.
- Certain cardiomyopathies or structural heart diseases causing heart failure except dilated ischemic or non-ischemic cardiomyopathy.
- Known allergy or contraindication to procedure medications or materials.
- Allergy to nickel or titanium.
- Contraindications to transesophageal echocardiography imaging.
- Left ventricular ejection fraction 30% or less.
- Severe mitral annular calcification, stenosis, vegetations, or masses.
- Extensive mitral valve leaflet flail.
- New or untreated intracardiac thrombus, mass, or vegetation.
- Severe right ventricular dysfunction.
- Severe tricuspid valve leakage.
- Significant inter-atrial shunt.
- Severe aortic valve leakage or stenosis.
- Anatomical ineligibility for the SATURN TS Bioprosthetic System or procedure as determined by screening committee.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Actively Recruiting
2
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
3
Warsaw Medical University
Warsaw, Poland
Actively Recruiting
Research Team
V
VP, Clinical Affairs InnovHeart
CONTACT
M
Maxis Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here