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
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Through 5 years
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Bapat, Vinayak, Vivek Rajagopal, Christopher Meduri, R. Saeid Farivar, Antony Walton, Stephen J. Duffy, Robert Gooley, et al.. 2018. “Early Experience with New Transcatheter Mitral Valve Replacement”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2017.10.061.
- Zahr, Firas, Howard K. Song, Scott M. Chadderdon, Hemal Gada, Mubashir Mumtaz, Timothy Byrne, Merick Kirshner, et al.. 2022. “30-day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2021.10.018.
- 2015. "Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study & EFS of the TMVR Transseptal System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02322840.
Frequently Asked Questions
Is this clinical research currently open to enrollees?
"Affirmative. Information from clinicaltrials.gov 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
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
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