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

NCT04982406 | Completed DMC

• 1 other identifier: 2020P001189
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational study, the purpose of which is to:

1. 1.Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement.
2. 2.Correlate preprocedure ECG features with changes in AV nodal and infranodal conduction during placement of the valve prosthesis.
3. 3.Correlate changes in AV nodal and infranodal conduction during the procedure with risk of developing AV conduction block after TAVR.
4. 4.Assess the contribution of stressing the conduction system by atrial pacing prior to and following TAVR to prediction of postprocedural heart block.

Conditions

Aortic Stenosis; Transcatheter Aortic Valve Replacement; Heart Block

Outcome Measures

Primary Outcomes (1)

• Heart block

  We will prospectively follow patients for the development of heart block requiring permanent pacemaker implantation, and identify factors associated with heart block following TAVR..

  30 days following procedure

Interventions

Transcatheter aortic valve replacement DEVICE

Transcatheter aortic valve replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic stenosis or regurgitation planned to undergo transcatheter aortic valve replacement

You may qualify if:

• patients undergoing elective TAVR at BIDMC

You may not qualify if:

• patients with permanent implanted pacemakers or ICDs prior to TA

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Alfred Buxton

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Poulin MF, Ultimo B, Omar W, Rathakrishnan BG, Haouzi A, Pinto DS, Buxton AE, Laham RJ. Routine Electrophysiology Study During Transcatheter Aortic Valve Replacement: A Safety and Feasibility Pilot Study. JACC Cardiovasc Interv. 2023 Oct 23;16(20):2584-2586. doi: 10.1016/j.jcin.2023.07.017. Epub 2023 Sep 20. No abstract available.

  PMID: 37737796 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Block

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Alfred Buxton, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shlomo Ben-Haim, MD - Mark E. Josephson, MD, Professor of Medicine in Field of Cardiac Electrophysiology

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 29, 2021
• Study Start: May 18, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 21, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)