Status:
COMPLETED
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedu...
Detailed Description
The study will be conducted in three phases. Subjects who have been treated commercially with TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1. Once consented p...
Eligibility Criteria
Inclusion
- Phase 1 - Starts after the TAVR procedure and prior to discharge • Patients treated commercially with TAVR with a SAPIEN 3 valve
- Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
- • Patients enrolled in Phase 1
Exclusion
- Phase 1 - Starts after the TAVR procedure and prior to discharge
- Stroke during or immediately after the TAVR procedure prior to discharge
- Inability to walk
- Non-English speaking (because the mobile app and CAT questionnaires are only in English)
- Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments. These limitations may include, but are not limited to: blindness, neuropathy, severe tremor or disabling motor deficit, cognitive impairment (documentation of dementia in the medical record), or illiteracy.
- Unwillingness or inability of the subject to provide informed consent for Phase 1 (no LARs allowed)
- Planned discharge from hospital to skilled nursing or rehabilitation facility
- Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
- All exclusion criteria from Phase 1 apply
- Stroke during Phase 1
- Residing in a skilled nursing facility at the 30 day post-TAVR follow-up visit
- Patients with unreliable use of the iPad mobile app or Fitbit during Phase 1 (e.g. not wearing the Fitbit at least 10 waking hours a day for at least 5 days a week)
- Unwillingness or inability of the subject to provide informed consent for Phases 2/3 (no LARs allowed)
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03270124
Start Date
November 7 2017
End Date
March 25 2020
Last Update
April 1 2021
Active Locations (5)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
Atlantic Health - Morristown Medical Center
Morristown, New Jersey, United States, 07960
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203