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Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System

NCT03714412 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-07

No results posted yet for this study

Summary

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

Implantation

Implantation of the Cardiovalve transfemoral mitral valve replacement system

Sponsors & Collaborators

  • Cardiovalve Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2019-12-15
Completion
2023-12-15

Countries

  • Greece
  • Poland

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 NCT03714412 on ClinicalTrials.gov