Cardiovalve Transfemoral System - FIM Study

Cardiovalve

Status

Enrolling

Conditions

Mitral Regurgitation

Treatments

Device: Cardiovalve transfemoral Mitral valve system

Study type

Interventional

Funder types

Industry

Identifiers

NCT03958773

CP 17-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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