Mitral Valve Regurgitation
Ravi Vallabhan, MD, FACC
Type of study:
Interventional -- multi-center, global, prospective, randomized, interventional pre-market trial
This study evaluates whether TMVR is non-inferior to conventional mitral valve surgery at one year for patients with severe symptomatic native mitral regurgitation. Study subjects are randomized on a 1:1 basis to either TMVR with the Medtronic Intrepid™ TMVR System or to conventional mitral valve surgery to compare treatment efficacy.
“I have had a significant interest in valvular heart disease since starting my practice in 1996. For me, Transcatheter Aortic Valve Replacement (TAVR) has been a truly revolutionary technology for the treatment of aortic valve stenosis since 2011 in the US. The impact on the treatment of AV stenosis has been far greater than most cardiologists and the medical community in general ever expected in such a short period of time. This has resulted in significant interest in percutaneous options for the treatment of mitral valve (MV) disease (both stenosis and regurgitation), which is the next major frontier in the treatment of valvular heart disease. We are one of a few select centers in the country chosen to participate in the APOLLO trial. This trial uses an intervention for patients with severe mitral regurgitation and is a truly revolutionary design for this type of valve. This trial is important as many previous percutaneous MV therapies have failed and the search for a consistently viable option is continuing. If successful, it will greatly increase the scope of patients for which we can offer transcatheter therapies for severe mitral regurgitation. This trial is important in helping establish Baylor Heart and Vascular Hospital - Dallas and Baylor University Medical Center as a leading center for the treatment of all types of valvular heart disease, both from a surgical and percutaneous approach.” Ravi Vallabhan, MD, principal investigator
The study will compare participants with mitral valve regurgitation who are treated with the Medtronic Transcatheter Mitral Valve Replacement System to those who a treated with conventional Surgical Mitral Valve Replacement. Primary outcomes measures include all-cause mortality, all stroke, reoperation or reintervention, and cardiovascular hospitalization.
Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT03242642?term=Medtronic+Intrepid+TMVR&cond=Mitral+Regurgitation&cntry=US&state=US%3ATX&city=Dallas&rank=1
Emily Laible, RN, BSW, CCRC, Emily.Laible@BSWHealth.org, 214.820.9903