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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Heart Block; Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

Detailed Description

Study Population:

Inclusion criteria -all patients undergoing elective TAVR Exclusion criteria -patients with permanent implanted pacemakers or ICDs prior to TAVR

1. Record standard 12-lead ECG prior to procedure.
2. Place standard electrode catheter via a venous sheath prior to TAVR
3. Initially place the catheter in a proximal position with a large atrial electrogram and proximal His electrogram.
4. Record baseline His bundle electrogram. Record baseline AH and HV intervals.
5. Pace the atrium starting at a cycle length 100 ms shorter than the sinus cycle length, progressively reducing the paced cycle length in 20 ms decrements after 3 seconds pacing at each cycle length, while continuously monitoring arterial blood pressure, to A-V block.
6. Advance the distal electrodes while maintaining recording of a His bundle electrogram to a position where stable right ventricular pacing is secured. Record the RV pacing threshold.
7. If a stable right ventricular pacing position together with stable His bundle electrogram cannot be achieved, a second venous temporary pacing wire will be placed.
8. Record presence or absence of retrograde conduction during RV pacing at 4 times pacing threshold.
9. Ensure stable continuous His bundle electrogram recording while the aortic valve prosthesis is deployed.
10. Use the distal electrodes for rapid ventricular pacing at 4 times threshold during deployment of the valve prosthesis.
11. After the prosthesis has been deployed and is deemed stable, just prior to removing the RV catheter, record a final HBE (AH, HBE, SCL) and again pull back catheter to enable atrial capture with proximal electrodes - pace as above to AV block: start starting at a cycle length 100 ms shorter than the sinus cycle length, progressively reducing the paced cycle length in 20 ms decrements after 3 seconds pacing at each cycle length while monitoring continuous arterial blood pressure to A-V block.
12. Record 12-lead ECG after completion of the procedure and daily thereafter until hospital discharge.
13. Standard telemetry monitoring post procedure while hospitalized.
14. Upon hospital discharge place a standard continuous ambulatory ECG monitor for 2 weeks in patients that do not have a pacemaker implanted.

• Study Type: Observational
• Enrollment (Estimated): 410

Contacts and Locations

• Study Contact: Name: Alfred E Buxton, MD; Phone Number: 617-632-9209; Email: abuxton@bidmc.harvard.edu
• Study Contact Backup: Name: Roger Laham, MD; Phone Number: 617-632-7597; Email: rlaham@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Alfred Buxton
      • Contact: Alfred Buxton, MD; Phone Number: 617-632-9209; Email: abuxton@bidmc.harvard.edu
      • Contact: Roger Laham, MD; Phone Number: 617-632-7597; Email: rlaham@bidmc.harvard.edu
      • Principal Investigator: Alfred E Buxton, MD
      • Sub-Investigator: Roger Haham, MD
      • Sub-Investigator: Mark Tuttle, MD
      • Sub-Investigator: Marie-France Poulin, MD
      • Sub-Investigator: David Liu, MD
      • Sub-Investigator: Venkatachalam Senthilnathan, MD
      • Sub-Investigator: Beatie Ultimo, NP
      • Sub-Investigator: Kim Guibone, NP
      • Sub-Investigator: Andre D'Avila, MD
      • Sub-Investigator: Patricia Tung, MD
      • Sub-Investigator: Jonathan Waks, MD
      • Sub-Investigator: Duane Pinto, MD
      • Sub-Investigator: Louis Chu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• patients undergoing elective TAVR at BIDMC

Exclusion Criteria:

• patients with permanent implanted pacemakers or ICDs prior to TA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Alfred Buxton, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Block; Cardiac Conduction System Disease
• Other Study ID Numbers: 2020P001189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Global Results will be published, not individual patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No