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NCT03107897 · ClinicalTrials.gov registry record · NA
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
A NA study of Aortic Valve Stenosis, sponsored by WellSpan Health.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03107897: Completed NA study of Aortic Valve Stenosis, sponsored by WellSpan Health.
NCT03107897 is a NA study of Aortic Valve Stenosis that has completed, run by WellSpan Health. The registered enrollment target is 35 participants, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03107897, a NA study of Aortic Valve Stenosis, has completed, sponsored by WellSpan Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation 1. to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and 2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.
Primary Outcome
Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT?
Conditions Studied
Interventions
- OTHER Pre-habilitation
Study Locations (1)
Pennsylvania
- Wellspan York Hospital - York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-08-17 |
| Est. Completion | 2021-04-30 |
| Phase | NA |
What the finished NCT03107897 record still lists
NCT03107897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Pre-habilitation is the first listed.
NCT03107897 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03107897 about?
NCT03107897 is a clinical study titled "Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement". In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. La...
What is the current status of trial NCT03107897?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2016-08-17. Estimated completion is 2021-04-30.
What conditions does trial NCT03107897 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis.
What interventions are being tested in trial NCT03107897?
The interventions under investigation include: Pre-habilitation (OTHER).
Who is sponsoring clinical trial NCT03107897?
This trial is sponsored by WellSpan Health, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03107897 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03107897's enrollment target sits among peer trials
35 30th of 30 higher than 1 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis 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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