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NCT04982406 · ClinicalTrials.gov registry record
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
A clinical trial, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 409
- Enrollment target
NCT04982406: Completed study, sponsored by Beth Israel Deaconess Medical Center.
NCT04982406 is a clinical trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 409 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04982406 has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 409 participants
- Enrollment target
Study Summary
This is a prospective observational study, the purpose of which is to: 1. Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement. 2. Correlate preprocedure ECG features with changes in AV nodal and infranodal conduction during placement of the valve prosthesis. 3. Correlate changes in AV nodal and infranodal conduction during the procedure with risk of developing AV conduction block after TAVR. 4. Assess the contribution of stressing the conduction system by atrial pacing prior to and following TAVR to prediction of postprocedural heart block. Assess the correlation between new onset bundle branch block, site and degree of conduction block or delay and subsequent development of high-grade or complete AV block.
Primary Outcome
We will prospectively follow patients for the development of heart block requiring permanent pacemaker implantation, and identify factors associated with heart block following TAVR..
Interventions
- DEVICE Transcatheter aortic valve replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2025-01-21 |
What the finished NCT04982406 record still lists
NCT04982406 is an observational study that tracks outcomes without assigning an intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Transcatheter aortic valve replacement is the first listed.
NCT04982406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04982406 about?
NCT04982406 is a clinical study titled "Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System". This is a prospective observational study, the purpose of which is to: 1. Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement. 2. Correlate preprocedure ECG features with changes in AV nodal and inf...
What is the current status of trial NCT04982406?
This trial is currently completed. The enrollment target is 409 participants. The study started on 2021-05-18. Estimated completion is 2025-01-21.
What interventions are being tested in trial NCT04982406?
The interventions under investigation include: Transcatheter aortic valve replacement (DEVICE).
Who is sponsoring clinical trial NCT04982406?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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