Twelve TMVR Implant for Mitral Valve Regurgitation

Phase-Based Progress Estimates
University of Virginia Medical Center, Charlottesville, VAMitral Valve RegurgitationTwelve TMVR Implant - Device
All Sexes
What conditions do you have?

Study Summary

This trial is to test the safety and effectiveness of a new mitral valve replacement system in people with severe, symptomatic mitral regurgitation.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Through 5 years

30 days
Adverse Events
Through 5 years
Procedural Success (Number of patients with successful TMVR placement)
Reduction of MR (Number of patients with a reduction of MR Grade)

Trial Safety

Trial Design

1 Treatment Group

TMVR Implant
1 of 1

Experimental Treatment

110 Total Participants · 1 Treatment Group

Primary Treatment: Twelve TMVR Implant · No Placebo Group · N/A

TMVR Implant
Experimental Group · 1 Intervention: Twelve TMVR Implant · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 5 years

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
74 Previous Clinical Trials
36,356 Total Patients Enrolled
MedtronicIndustry Sponsor
578 Previous Clinical Trials
748,123 Total Patients Enrolled
Sarah BrownStudy DirectorMedtronic

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have moderate to severe symptoms of a heart condition called mitral regurgitation.
The doctor believes that it is possible to access the heart through the chest area (PILOT study only).

Frequently Asked Questions

Is this clinical research currently open to enrollees?

"Affirmative. Information from demonstrates that this medical trial has been ongoing since April 1st of 2015 and is currently recruiting participants for enrollment, with 110 individuals required between 8 different sites. The study was last updated on November 21st 2022." - Anonymous Online Contributor

Unverified Answer

How many people have signed up to be included in this clinical trial?

"To execute this study, a total of 110 candidates who meet the necessary qualifications are needed. Medtronic Cardiovascular is managing this trial from medical facilities in Grand Rapids, Michigan and Portland, Oregon such as Spectrum Health Hospitals and Oregon Health Sciences University Hospital respectively." - Anonymous Online Contributor

Unverified Answer

To what extent is this experiment being conducted in the healthcare sector?

"This trial is taking place at Spectrum Health Hospitals in Grand Rapids, Michigan, Oregon Health Sciences University Hospital in Portland, Oregon, and Columbia in New York City as well as 8 other research centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.