Improving activity levels after aortic valve replacement
Official title: Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
Run by Johns Hopkins University · NCT06106451 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether a special program that combines motivation and home exercise can help people recover and be more active after getting a new heart valve through a minimally-invasive procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06106451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 65 and older who are undergoing a TAVR procedure and are ambulatory without assistance.
✕Probably not a fit
Patients with significant cognitive impairments, major cardiac comorbidities, or those who engage in vigorous exercise regularly may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates programs designed to enhance functional outcomes for patients following minimally-invasive transcatheter aortic valve replacement (TAVR). It compares the effectiveness of a motivational interviewing program and a home-based physical activity program combined with motivational interviewing against standard care with enhanced education. The goal is to determine which approach best supports recovery and activity levels in patients post-TAVR.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and increased activity levels for patients after aortic valve replacement.
How similar studies have gone: Other studies have shown promising results with motivational interviewing and physical activity interventions in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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The Johns Hopkins University
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Giancarlo Suffredini, MD — Johns Hopkins University
- Study coordinator: Charles Brown, MD
- Email: cbrownv@jhmi.edu
- Phone: 410-955-9918
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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KONECT RESILIA Aortic Valved Conduit real-world use in adults needing valve and ascending aorta replacement
This study tests how the KONECT RESILIA aortic valved conduit performs in adults needing aortic valve and ascending aorta replacement.
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Savvywire versus standard LV guidewires during transfemoral TAVI
For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.
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EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis
This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.
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Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
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Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults
This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.
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Transcatheter JenaValve or J-Valve treatment for severe aortic regurgitation
This project will try two transcatheter heart valves (JenaValve and J-Valve) to treat people with severe symptomatic aortic regurgitation who are high risk for open-heart surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.