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Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study) | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT06106451•Johns Hopkins University

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 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

The Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

January 29, 2024

Primary Completion Date

October 14, 2025

Completion Date

November 3, 2025

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Aortic Valve DiseaseAortic Valve Replacement

Interventions

Standard of Care plus Enhanced Patient Education

BEHAVIORAL

Motivational Interviewing Intervention

BEHAVIORAL

Home-Based Activity Program plus Motivational Interviewing Intervention

BEHAVIORAL

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

View study

RECRUITINGNA

J-Valve Transfemoral Pivotal Study

NCT06455787

Aortic Valve RegurgitationAortic Valve Disease Mixed

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

J-Valve Transfemoral Pivotal Study

Prospective Long-Term Outcomes of a Standardized Ross Procedure

Valved Graft PMCF Study

Short Versus Long Antiplatelet Therapy After TAVI

Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation