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Clinical Trials in Italy / NCT05010746
Active, not recruiting Not applicable

TVMR With the Innovalve System Trial - Pilot Study in Italy

NCT05010746 · tracked via the Priya Life Science Italy tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2023-01-24
Last updated
2025-06-26

Condition(s) studied

Mitral Valve Regurgitation (Degenerative or Functional)

Investigational drug(s) / intervention(s)

Innovalve TMVR system

Innovalve TMVR system: Innovalve TMVR system

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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%

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Humanitas Milan Italy

More Edwards Lifesciences trials in Italy

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MiCLASP Post Market Clinical Follow-Up (PMCF) Study Active, not recruiting
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System Active, not recruiting
SAPIEN 3 Ultra System PMCF Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05010746 on ClinicalTrials.gov ↗ ← All trials in Italy