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

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ClinicalTrials.gov Identifier: NCT02723422
Recruitment Status : Withdrawn
First Posted : March 30, 2016
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Transcatheter Aortic Valve Replacement (TAVR) Procedure: Prehabilitation visit/increased physical therapy post-TAVR Procedure: Standard of Care Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial
Study Start Date : January 2017
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Prehabilitation Visit/Increased Physical Therapy post-TAVR 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

Active Comparator: Control
Standard of care physical therapy post-TAVR
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Reduction in hospital readmissions following intensive home-based physical therapy reduces [ Time Frame: Baseline, 2 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723422


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: John Dodson, MD New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02723422     History of Changes
Other Study ID Numbers: 15-01098
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017