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Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System

NCT04982406 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 409

Last updated 2025-01-24

No results posted yet for this 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.

Conditions

  • Aortic Stenosis
  • Transcatheter Aortic Valve Replacement
  • Heart Block

Interventions

DEVICE

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement

Sponsors & Collaborators

Principal Investigators

  • Alfred Buxton, MD · Beth Israel Deaconess Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2024-01-30
Completion
2025-01-21

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982406 on ClinicalTrials.gov