Cardiovalve Transfemoral System - FIM Study

NCT ID: NCT03958773

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-12
• Study Completion Date: 2026-10-30

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.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiovalve treatment

Patients that implanted with the Cardiovalve device

Group Type: EXPERIMENTAL

Cardiovalve transfemoral Mitral valve system

Intervention Type: DEVICE

Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.

Interventions

Cardiovalve transfemoral Mitral valve system

Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.

Intervention Type: DEVICE

Eligibility 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
• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meditrial Europe Ltd.

INDUSTRY

Sponsor Role: collaborator

Cardiovalve Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rimantas Benetis, MD

Role: PRINCIPAL_INVESTIGATOR

Head of department

Locations

Hospital of the Lithuanian University of Health Sciences ligoninė Kauno

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

CP 17-01

Identifier Type: -

Identifier Source: org_study_id