Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

NCT ID: NCT02723422

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-01-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prehabilitation Visit/Increased Physical Therapy post-TAVR

Group Type: EXPERIMENTAL

Prehabilitation visit/increased physical therapy post-TAVR

Intervention Type: 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

Control

Standard of care physical therapy post-TAVR

Group Type: ACTIVE_COMPARATOR

Standard of Care Arm

Intervention Type: 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.

Interventions

Prehabilitation 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

Intervention Type: PROCEDURE

Standard 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Dodson, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Other Identifiers

15-01098

Identifier Type: -

Identifier Source: org_study_id