Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

NCT02723422 | Withdrawn

• 1 other identifier: 15-01098
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transcatheter Aortic Valve Replacement (TAVR)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  Baseline, 2 Weeks

Study Arms (2)

Prehabilitation Visit/Increased Physical Therapy post-TAVR

EXPERIMENTAL

Procedure: Prehabilitation visit/increased physical therapy post-TAVR

Control

ACTIVE COMPARATOR

Standard of care physical therapy post-TAVR

Procedure: Standard of Care Arm

Interventions

Prehabilitation visit/increased physical therapy post-TAVR PROCEDURE

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

Prehabilitation Visit/Increased Physical Therapy post-TAVR

Standard of Care Arm PROCEDURE

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.

Control

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
• Non-English/non-Spanish speaking.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Officials

• John Dodson, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 30, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 30, 2017

Record last verified: 2017-01