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

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04982406
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis; Transcatheter Aortic Valve Replacement; Heart Block	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
• Actual Study Start Date: May 18, 2021
• Anticipated Primary Completion Date: May 18, 2023
• Anticipated Study Completion Date: May 18, 2024

Outcome Measures

Primary Outcome Measures

1. Heart block [30 days following procedure]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients undergoing elective TAVR at BIDMC

Exclusion Criteria:

• patients with permanent implanted pacemakers or ICDs prior to TA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alfred Buxton	Needham	Massachusetts	United States	02492

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alfred Buxton, Shlomo Ben-Haim, MD - Mark E. Josephson, MD, Professor of Medicine in Field of Cardiac Electrophysiology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04982406
• Other Study ID Numbers: 2020P001189
• First Posted: Jul 29, 2021
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Stenosis; Heart Block; Cardiac Conduction System Disease

Study Results

No Results Posted as of Jul 25, 2022