Aortic Valve Stenosis Clinical Trial
Official title:
A Supervised TAVR Exercise Program (STEP) for Patients Prior to Undergoing Transcatheter Aortic Valve Replacement (TAVR): A Pilot Study
The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).
TAVR is an approved alternative therapy for patients with severe aortic valve stenosis who
are deemed inoperable or high-risk for surgical aortic valve replacement (SAVR). Despite a
very high procedural success rate (>95%), mortality rates after TAVR at 1- and 2-year
follow-up remain ≥25% and ≥34%, respectively. It is becoming increasingly evident that
frailty, as a clinical syndrome, has a large impact on this long term mortality. In a study
by Green, et al. frailty status was independently associated with increased 1-year mortality
(OR=3.5) after TAVR. The investigators' own retrospective analysis showed that impaired
mobility and malnutrition were significantly associated with a longer hospital length of stay
(5 days vs. 3 days), and increased total cost (on average, an additional $10,000 per
patient). Given the phenotype of frailty is characterized by reductions in muscle mass,
strength, endurance and activity level, a STEP is ideally suited to counteract these
impairments. This pilot study aims to establish whether a STEP can safely improve the frailty
score in patients with symptomatic severe aortic valve stenosis prior to undergoing TAVR.
This single-center pilot study will be conducted in partnership between Heart Care Midwest
(HCMW), OSF St. Francis Medical Center (OSF SFMC), and University of Illinois College of
Medicine at Peoria (UICOMP). UICOMP Center of Outcomes Research will provide analytical
support. The study will be funded by an operational research grant from OSF SFMC.
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