Replacement valve for patients with severe mitral regurgitation
Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
This study is testing a new valve replacement system for people with severe mitral regurgitation who can't have traditional surgery to see if it helps them feel better and improves their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiovalve Ltd. Industry-sponsored |
| Locations | 1 site (Kaunas) |
| Trial ID | NCT03958773 on ClinicalTrials.gov |
What this trial studies
The Cardiovalve system is designed to replace the mitral valve using a transfemoral access and transseptal approach for patients suffering from severe mitral regurgitation who are not candidates for traditional surgical options. This study aims to evaluate the safety and performance of the Cardiovalve system, focusing on its ability to reduce mitral regurgitation and improve patient outcomes. Data will be collected on the device's performance over a 30-day period and long-term clinical outcomes will be monitored for up to two years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe mitral regurgitation who are at high risk for conventional surgery.
Not a fit: Patients with recent strokes, acute myocardial infarction, or prior heart valve surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with severe mitral regurgitation, improving their quality of life and clinical outcomes.
How similar studies have performed: Other studies have explored similar minimally invasive approaches for mitral valve replacement, showing promising results, but this specific device and methodology are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria (assessed by pre-procedural imaging) * Left Ventricular Ejection Fraction ( LVEF) \<30% * LV end diastolic diameter \> 70mm * Significant abnormalities of the mitral valve and sub-valvular apparatus. * Severe mitral annular or leaflets calcification * Left atrial or LV thrombus * Severe right ventricular dysfunction * Severe tricuspid or aortic valve disease General Exclusion Criteria * Subject who is currently participating in an investigational study, other than this study * Hemodynamic instability defined as systolic pressure \< 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance * Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications * Bleeding diathesis or hypercoagulable state * Active peptic ulcer or active gastrointestinal bleeding * Pulmonary artery systolic pressure \>70 mmHg * Patients with renal insufficiency (creatinine \> 2.5 mg/dL) * Subject with hepatic insufficiency * Subject has a co-morbid illness that may result in a life expectancy of less than one year * Active infection that requires antibiotic therapy * Subject is pregnant, breastfeeding or intend to become pregnant within one year
Where this trial is running
Kaunas
- Hospital of the Lithuanian University of Health Sciences ligoninė Kauno — Kaunas, Lithuania (Recruiting)
Study contacts
- Principal investigator: Rimantas Benetis, MD — Head of department
- Study coordinator: Nitza Shoham, PhD
- Email: nitza@cardiovalve.com
- Phone: +972765388142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.