Mitral Regurgitation
Conditions
Brief summary
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.
Detailed description
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.
Interventions
DEVICEImplantation
Implantation of the Cardiovalve transfemoral mitral valve replacement system
Sponsors
Cardiovalve Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 2\. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology 4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated. 5\. Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities. 6\. Able to undergo Transesophageal Echocardiography (TEE). 7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. 8\. The subject commits to return for the scheduled post-operative follow-up visits at the hospital. Anatomical Inclusion Criteria 9. Suitable for femoral access procedure and trans septal catheterization 10. Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)
Exclusion criteria
Cardiovascular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major device- or procedure- related serious adverse events | 30 days | Evaluate the safety of the Cardiovalve with its associated procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of delivery and deployment of the device | Intraoperative | Technical success of delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis |
| Freedom from emergency surgery or reintervention | 30 days | Freedom from emergency surgery or reintervention related to the device or access procedure |
| Freedom from rehospitalizations or reinterventions due to the underlying condition | 30 days, 3 Months, 6 Months, 12 Months, and 24 Months | Freedom from rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, worsening of heart failure) |
| Reduction in MR grade | 30 days, 3-, 6-, 12 and 24-months | Reduction in MR grade to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) Number of patients with reduction in MR grade from baseline |
| NYHA class | 30 days, 3-, 6-, 12 and 24-months | Improvement from baseline in NYHA functional class; Number of patients with improvement in NYHA class |
| 6 minute walk test | 30 days, 3-, 6-, 12 and 24-months | Increase in distance from baseline |
| Improvement in quality of life from baseline | 30 days, 3-, 6-, 12 and 24-months | Improvement from baseline in quality-of-life (Kansas City Cardiomyopathy Questionnaire improvement by ≥ 10) |
Countries
Greece, Poland
Outcome results
None listed