Mitral Regurgitation
Conditions
Keywords
Mitral valve, Functional mitral regurgitation, Heart failure
Brief summary
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
Detailed description
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible. The purpose of this study is to evaluate the safety of the CardiovalveSystem 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 of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
Interventions
DEVICECardiovalve transfemoral Mitral valve system
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
Sponsors
Meditrial Europe Ltd.
Cardiovalve Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-center, single-arm feasibility clinical study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * NYHA functional II, III or ambulatory IV * Severe mitral regurgitation (MR grade 3-4+) * High 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) * Able to undergo Transesophageal Echocardiography (TEE). * Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. * The subject commits to return for the scheduled post-operative follow-up visits at the hospital. * Suitable for femoral access procedure and transseptal catheterization * Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve
Exclusion criteria
* Prior stroke or TIA within 3 months * Acute myocardial infarction within the previous 30 days * Any prior heart valve surgery or transcatheter mitral intervention * Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days * Rheumatic heart disease or endocarditis within the previous 3 months * 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 * Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization) * Untreated clinically significant coronary artery disease requiring revascularization * Tricuspid valve disease requiring surgery or severe tricuspid regurgitation * Aortic valve disease requiring surgery Anatomical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major device or procedure related serious adverse events | 30 days | Freedom from major device or procedure related serious adverse events: F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h. I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Intraoperative | Technical success; 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 Number of patients for whom the device was successfully implanted (per MVARC definitions) Number of patients with reduction in MR grade from Baseline Number of patients with improvement in NYHA class from baseline Number of patients with increase distance walked in the 6MW test from baseline. |
Countries
Lithuania
Outcome results
None listed