Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)

Submitted by centretek on Sat, 10/15/2022 - 10:29
Source URL
https://www.inova.org/clinical-trials/transcatheter-mitral-valve-replacement-medtronic-intrepidtm-tmvr-system-patients
Description
General Information Age Group Adults Status Recruiting Protocol Number 056-F275 Background Information Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation who are candidates for conventional mitral valve surgery. Offered At Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 Principal Investigator Shahram Yazdani, MD Eric Sarin, MD Eligibility Information Subject has moderate to severe or severe symptomatic mitral regurgitation Heart Team agrees that patient is a candidate for bioprosthetic mitral valve replacement Ineligibility Information Subject has comorbidities such that the Heart Team agrees predicted risk of operative mortality is < 3% at 30 days or has ≥ 35% risk of mortality or irreversible major morbidity at 30 days Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions Subject with mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing Prior mitral valve surgery including previously implanted mitral valve, ring, or band Contact Information Contact Name Ana Villagomez Contact Phone 703-776-6007, Fax 703-776-8018 Contact Email Send Email
Clinical Trials Sub categories
Heart
Crawled Content Type
Clinical Trials
Summary
Mitral valvular disease, and specifically mitral valve regurgitation is the most common valve disease in the US. Currently mitral valve surgery (open heart surgery), either with repair or replacement, is the standard of care for patients with symptomatic mitral valve disease. Transcatheter mitral valve replacement (TMVR) is an emerging therapy that could offer patient a less invasive alternative to open heart surgery. The goal of the APOLLO trial is to evaluate whether TMVR is non-inferior to conventional mitral surgery with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic native mitral regurgitation. The secondary objectives of this trial are to assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with severe symptomatic native mitral regurgitation.
Age Group
Adults
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