Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial (TAVR-PT)

NYU Langone Health

Status: Withdrawn

Conditions: Transcatheter Aortic Valve Replacement (TAVR)

Treatments: Procedure: Standard of Care Arm; Procedure: Prehabilitation visit/increased physical therapy post-TAVR

Study type: Interventional

Funder types: Other

Identifiers

NCT02723422

15-01098

Details and patient eligibility

About

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.

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Prehabilitation Visit/Increased Physical Therapy post-TAVR

Experimental group

Treatment:

Procedure: Prehabilitation visit/increased physical therapy post-TAVR

Control

Active Comparator group

Description:

Standard of care physical therapy post-TAVR

Treatment:

Procedure: Standard of Care Arm