A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement

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 prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m
walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and
answer quality of life questions on the iPad about their activities and quality of life.
After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair
stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently
provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and
complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be
randomized to one of two arms. In one arm, they will have a daily activity goal and
resistance exercises; in the other arm, there will not be a daily activity goal and no
resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6
minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as
well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to
track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS
Questionnaires, and end of study questionnaire.

Inclusion Criteria:

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 Criteria:

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)