TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

N/AWithdrawnNCT05263375

Innovalve Bio Medical Ltd.

Overview

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

Innovalve TMVR systemDEVICE

Innovalve TMVR system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Patient is inoperable * EF \<30%

Outcomes

Primary Outcomes

Number of patients with implant or delivery related serious adverse events at 30 days

Time frame: 30 days

Data from ClinicalTrials.gov

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