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Cardiovalve Transfemoral System - FIM Study

NCT03958773 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-05

No results posted yet for this study

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

Interventions

DEVICE

Cardiovalve transfemoral Mitral valve system

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

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Cardiovalve Ltd.

    lead INDUSTRY

Principal Investigators

  • Rimantas Benetis, MD · Head of department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2026-10-30
Completion
2026-10-30

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958773 on ClinicalTrials.gov