Tests the Cardiovalve mitral valve device in people with leaky mitral valves

Trial details

Who runs it

Cardiovalve Ltd.

Trial code

NCT03958773

Record updated

5 January 2026

Original 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.Read full original descriptionShow less

Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation

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.

Inclusion: 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: 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; 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); Severe tricuspid or aortic valve disease General Exclusion Criteria; 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; 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; Left Ventricular Ejection Fraction ( LVEF) <30%; Patients with renal insufficiency (creatinine > 2.5 mg/dL); Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization); 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; Subject who is currently participating in an investigational study, other than this study; Pulmonary artery systolic pressure >70 mmHg; Subject is pregnant, breastfeeding or intend to become pregnant within one year.

ClinicalTrials.gov NCT03958773