Active, not recruitingNCT02322840

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

Name: UPMC Harrisburg
Address: Harrisburg, PA

Medtronic CardiovascularMultiple US sitesView on ClinicalTrials.gov

AI Description

PILOT:

The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.

EFS:

The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation

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Who can join: adult, older adult
Participants: 128
Expected completion: 2028-12
Funded by: industry

Conditions studied

Mitral Valve Insufficiency

What is being tested

DEVICE: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
DEVICE: Twelve TMVR Implant

What it measures

Percent of Subjects With Adverse Events, PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure, 30 days