Heart Failure
Conditions
Brief 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)
Detailed description
The SATURN Trans-Septal Transcatheter Mitral Valve Replacement System (SATURN TS System) is intended for use in adult patients suffering from heart failure symptoms (NYHA class II or greater) with moderate to severe or severe mitral regurgitation (MR ≥3+) who are deemed to be at high risk for open-heart mitral valve surgery by a multidisciplinary Heart Team including at least a cardiac surgeon and a cardiologist, experienced in the care of patients with mitral valve disease. CASSINI-EU is a single-arm, prospective, multicenter pilot trial. The purpose of the study 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. Primary objectives are to evaluate the feasibility, safety and performance of the SATURN TS TMVR System at 30 days. Secondary objectives and additional outcomes are long term safety and performance of the SATURN TS TMVR System. Up to 30 patients will be treated at up to 6 qualified investigational sites in Europe.
Interventions
The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.
Sponsors
InnovHeart
Avania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint - Freedom from Device Related Major Adverse Events | 30 days post-procedure | Freedom from device-related major adverse events |
| Technical Procedural Success Endpoint | Procedure | Technical success defined as alive patient at exit from procedure room with all the following: * Successful access, delivery of the SATURN TS Bioprosthesis, and retrieval of the TS Delivery Systems * Correct positioning of the first intended SATURN TS Bioprosthesis * Freedom from emergency surgery or mitral valve re-intervention related to the device or access procedure |
| Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+ | 30 days post-procedure | Reduction of MR Grade to ≤ 1+ |
Countries
Georgia, Italy, Lithuania, Poland, United Kingdom
Contacts
CONTACTVP, Clinical Affairs InnovHeart
CONTACTMaxis Operations
PRINCIPAL_INVESTIGATORPaolo Denti, MD
San Raffaele Hospital
Outcome results
None listed