Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Study arms

• Experimental
  Prehabilitation Visit/Increased Physical Therapy post-TAVR

  Procedure: Prehabilitation visit/increased physical therapy post-TAVR

• Active comparator
  Control

  Standard of care physical therapy post-TAVR

  Procedure: Standard of Care Arm

Interventions

• ProcedurePrehabilitation visit/increased physical therapy post-TAVR

  Prior to TAVR, patients randomized to the intervention arm will meet with a licensed physical therapist for a 30-minute session in the ambulatory setting. Following TAVR, patients randomized to the intervention arm will receive 4 days per week of home-based physical therapy by a licensed physical therapist working for Revival Home Health Care

• ProcedureStandard of Care Arm

  Patients randomized to the usual care arm will receive home-based physical therapy for 2 days per week by Revival Home Health Care, which is the current standard of care.

Primary outcomes

1. Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.

   Time frame: Baseline, 2 Weeks

2. Change in self-perceived physical health

   Time frame: Baseline, 2 Weeks

3. Change in Independence in activities of daily living (ADLs).

   Time frame: Baseline, 2 Weeks

Secondary outcomes

1. Reduction in hospital readmissions following intensive home-based physical therapy reduces

   Time frame: Baseline, 2 Weeks