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Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Recruiting
65 years and older
All
Phase N/A

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Overview

In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR). The investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational interviewing program, compared to (c) usual care + enhanced education in patients post-TAVR procedure.

Eligibility

Inclusion Criteria:

  • Undergoing TAVR procedure
  • ≥65 years old
  • Ambulatory at baseline without assistance
  • Approval of the interventional cardiologist that the patient is an appropriate candidate
  • Can access telephone or teleconference

Exclusion Criteria:

  • Impaired cognition that would limit participation in study activities
  • Medical comorbidities that substantially limit exercise
  • Major cardiac comorbidities, including ejection fraction<35%, history of cardiac arrest, complex dysrhythmias at rest, clinically-significant incomplete revascularization, implanted cardiac defibrillator.
  • Physical characteristics that substantially limit exercise
  • High fall risk (Johns Hopkins Fall Risk Assessment Tool indicating high risk)
  • Non-English Speaking
  • Vigorous exercise at least 2 times/week for >30 minutes
  • Any other physician judgement

Study details
    Aortic Valve Disease
    Aortic Valve Replacement

NCT06106451

Johns Hopkins University

16 February 2024

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