Mitral Regurgitation, Mitral Valve Disease
Conditions
Keywords
Mitral Insufficiency, Heart Failure, Mitral Valve, Heart Diseases, Valvular Heart Disease
Brief summary
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.
Detailed description
The Cardiovalve offers a mitral replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible. Innovation: A truly trans femoral, trans venous delivery of the prosthetic mitral valve which minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust radial strength with decoupling of the atrial flange and ventricular portion which contains 24 grasping legs designed for atraumatic anchoring of the device to the native mitral annulus. Valve leaflets are made of bovine pericardium. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The Cardiovalve delivery system (DS) is designed for transfemoral delivery of the Implant with transseptal access to the left atrium. The catheter assembly is used to center the implant relative to the native mitral valve plane and align it with the left ventricual apex-to-base axis. After valve implantation, the delivery system is withdrawn.
Interventions
The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Sponsors
Cardiovalve Ltd.
Meditrial Europe Ltd.
Meditrial SrL
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 1. Age ≥ 18 years 2. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) 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) Cardiovascular
Exclusion criteria
1. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability 2. Acute myocardial infarction within the previous 30 days 3. Any prior heart valve surgery or transcatheter mitral intervention 4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days 5. Rheumatic heart disease or endocarditis within the previous 3 months 6. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology 7. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization) 8. Untreated clinically significant coronary artery disease requiring revascularization 9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation 10. Aortic or pulmonic valve disease requiring surgery 11. CRT/ICD implant within 30 days Anatomical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary safety endpoint is freedom from all-cause mortality and major adverse events | 30 days, 3 Months, 6 Months, 12 Months, and 24 Months | Freedom from all-cause mortality, all cause hospitalization, major adverse cardiac events (MACE), major device- or procedure- related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Intraoperative, 30 Days | Technical success: I. Absence of procedural mortality II. Delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging \[Time Frame:Intraoperative\] III. Freedom from emergency surgery or reintervention related to the device or access procedure \[Time Frame: 30 days\] |
| Device Success | Intraoperative | I. Absence of procedural mortality or stroke II. Proper placement and positioning of the device III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure |
| Patient Success | 30 days, 3 Months, 6 Months, 12 Months, and 24 Months | I. Device success (either optimal or acceptable) II. Patient returned to the pre-procedural setting * III. Freedom from rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, worsening of heart failure) * IV. Improvement from baseline in NYHA functional class Number of patients with improvement in NYHA class * V. Six minute walk test Increase in distance (m) from baseline * VI. Improvement from baseline in quality-of-life (Kansas City Cardiomyopathy Questionnaire improvement by ≥ 10) |
Countries
Germany, Greece, Italy
Contacts
PRINCIPAL_INVESTIGATORGeorg Nickenig
Bonn Clinic
Outcome results
None listed