Loading clinical trials...

Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study | Clinical Trials | Clareo Health

TERMINATEDNA

Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

NCT02428010•Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

Study to evaluate the safety and performance of the Twelve TMVR System

Detailed Description

The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Severe mitral regurgitation (MR Grade 3-4+)
•Symptomatic mitral regurgitation (NYHA Class II-IV)
•Trans-apical access deemed feasible by the treating physician
•Native mitral valve geometry and size compatible with the Twelve TMVR

Exclusion Criteria

•Left ventricular ejection fraction (LVEF) \< 20
•Evidence of intracardiac mass, thrombus, or vegetation
•Prior valve surgery or need for other valve surgery
•Prior stroke within 4 weeks
•Need for coronary revascularization
•History of, or active, endocarditis
•Renal insufficiency (Creatinine \> 2.5 mg/dL)

Locations (1)

John Paul II Hospital

Krakow, Poland

Key Dates

Start Date

September 1, 2014

Primary Completion Date

April 1, 2021

Completion Date

April 1, 2021

Last Updated

May 4, 2021

Enrollment

ACTUAL participants

Conditions

Mitral Valve Insufficiency

Interventions

TMVR Implant

DEVICE

DragonFly EU Pivotal Study

NCT05927441

Mitral Valve Insufficiency

View study

RECRUITINGNA

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Inclusion Criteria

Exclusion Criteria

DragonFly EU Pivotal Study

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study