Status:
RECRUITING
Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Catalyst Foundation
Conditions:
Aortic Valve Disease
Aortic Valve Replacement
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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)....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06106451
Start Date
January 29 2024
End Date
April 1 2027
Last Update
February 6 2025
Active Locations (1)
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1
The Johns Hopkins University
Baltimore, Maryland, United States, 21287