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Cardiovalve Transfemoral System - FIM Study

Mitral Regurgitation Clinical Trial

Official title:
Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03958773
Study type Interventional
Source Cardiovalve Ltd.
Contact Nitza Shoham, PhD
Phone +972765388142
Email nitza@cardiovalve.com
Status Recruiting
Phase N/A
Start date October 12, 2017
Completion date October 30, 2026
View Details
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