Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial
Not Applicable
Withdrawn
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR)
- Interventions
- Procedure: Standard of Care ArmProcedure: Prehabilitation visit/increased physical therapy post-TAVR
- Registration Number
- NCT02723422
- Lead Sponsor
- NYU Langone Health
- Brief Summary
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team
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Exclusion Criteria
- Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- Non-English/non-Spanish speaking.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Standard of Care Arm Standard of care physical therapy post-TAVR Prehabilitation Visit/Increased Physical Therapy post-TAVR Prehabilitation visit/increased physical therapy post-TAVR -
- Primary Outcome Measures
Name Time Method Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT. Baseline, 2 Weeks Change in self-perceived physical health Baseline, 2 Weeks Change in Independence in activities of daily living (ADLs). Baseline, 2 Weeks
- Secondary Outcome Measures
Name Time Method Reduction in hospital readmissions following intensive home-based physical therapy reduces Baseline, 2 Weeks