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

RECRUITINGN/ASponsored by Johns Hopkins University
Actively Recruiting
PhaseN/A
SponsorJohns Hopkins University
Started2024-01-29
Est. completion2026-09-30
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06106451

Summary

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

Age: 65 Years+Healthy volunteers accepted
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

Conditions3

Aortic Valve DiseaseAortic Valve ReplacementHeart Disease

Locations1 site

The Johns Hopkins University
Baltimore, Maryland, 21287
Charles Brown, MD410-955-9918cbrown12@jhmi.edu

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