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Cardiovalve Transfemoral Mitral Valve System

NCT03813524 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-08-06

No results posted yet for this study

Summary

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize 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 5 years.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

Cardiovalve Transfemoral Mitral Valve

The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.

Sponsors & Collaborators

  • Cardiovalve Ltd.

    collaborator INDUSTRY

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Boston Biomedical Associates

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03813524 on ClinicalTrials.gov