Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial

Transcatheter Aortic Valve Replacement (TAVR) Clinical Trial

— TAVR-PT  

Official title:

Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02723422
• Other study ID #: 15-01098
• Status: Withdrawn
• Phase: N/A
• First received: March 9, 2016
• Last updated: January 27, 2017
• Start date: January 2017
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement (TAVR)

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.		Baseline, 2 Weeks
Primary	Change in self-perceived physical health		Baseline, 2 Weeks
Primary	Change in Independence in activities of daily living (ADLs).		Baseline, 2 Weeks
Secondary	Reduction in hospital readmissions following intensive home-based physical therapy reduces		Baseline, 2 Weeks