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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 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
🗓️ Study Start (Actual) 18 May 2021
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 410
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * patients undergoing elective TAVR at BIDMC

    Exclusion Criteria:

    • * patients with permanent implanted pacemakers or ICDs prior to TA
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 July 2021
  • First Submitted that Met QC Criteria 20 July 2021
  • First Posted 29 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023
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