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NCT06106451 · ClinicalTrials.gov registry record · NA
Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
A NA study of Aortic Valve Disease and Aortic Valve Replacement, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06106451: Completed NA study of Aortic Valve Disease and Aortic Valve Replacement, sponsored by Johns Hopkins University.
NCT06106451 is a NA study of Aortic Valve Disease and Aortic Valve Replacement that has completed, run by Johns Hopkins University. The registered enrollment target is 40 participants, below the 18,614-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06106451, a NA study of Aortic Valve Disease and Aortic Valve Replacement, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This outcome will measure the number of motivational interviewing sessions in which the patient participates. Motivational Interviewing Arm Outcome.
Conditions Studied
Interventions
- BEHAVIORAL Standard of Care plus Enhanced Patient Education
- BEHAVIORAL Motivational Interviewing Intervention
- BEHAVIORAL Home-Based Activity Program plus Motivational Interviewing Intervention
Study Locations (1)
Maryland
- The Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2025-11-03 |
| Phase | NA |
What the finished NCT06106451 record still lists
NCT06106451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 18,614-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Aortic Valve Disease appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care plus Enhanced Patient Education is the first listed.
NCT06106451 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06106451 about?
NCT06106451 is a clinical study titled "Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)". 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...
What is the current status of trial NCT06106451?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2024-01-29. Estimated completion is 2025-11-03.
What conditions does trial NCT06106451 study?
This clinical trial studies the following conditions: Aortic Valve Disease, Aortic Valve Replacement.
What interventions are being tested in trial NCT06106451?
The interventions under investigation include: Standard of Care plus Enhanced Patient Education (BEHAVIORAL), Motivational Interviewing Intervention (BEHAVIORAL), Home-Based Activity Program plus Motivational Interviewing Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06106451?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06106451 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06106451's enrollment target sits among peer trials
40 12th of 15 higher than 3 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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