Cardiovalve Transfemoral System - FIM Study

NCT03958773 | Enrolling By Invitation DMC

• 1 other identifier: CP 17-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Keywords

Mitral valve; Functional mitral regurgitation; Heart failure

Outcome Measures

Primary Outcomes (1)

• Freedom from major device or procedure related serious adverse events

  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

  30 days

Secondary Outcomes (1)

• Technical success

  Intraoperative

Study Arms (1)

Cardiovalve treatment

EXPERIMENTAL

Patients that implanted with the Cardiovalve device

Device: Cardiovalve transfemoral Mitral valve system

Interventions

Cardiovalve transfemoral Mitral valve system DEVICE

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

Cardiovalve treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiovalve Ltd.: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (1)

Hospital of the Lithuanian University of Health Sciences ligoninė Kauno

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Rimantas Benetis, MD

  Head of department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-arm feasibility clinical study.

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 22, 2019
• Study Start: October 12, 2017
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)