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

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ClinicalTrials.gov Identifier: NCT04982406
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Alfred Buxton, Beth Israel Deaconess Medical Center

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : May 18, 2023
Estimated Study Completion Date : May 18, 2024



Intervention Details:
  • Device: Transcatheter aortic valve replacement
    Transcatheter aortic valve replacement


Primary Outcome Measures :
  1. Heart block [ Time Frame: 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..



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • patients undergoing elective TAVR at BIDMC

Exclusion Criteria:

  • patients with permanent implanted pacemakers or ICDs prior to TA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982406


Contacts
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Contact: Alfred E Buxton, MD 617-632-9209 abuxton@bidmc.harvard.edu
Contact: Roger Laham, MD 617-632-7597 rlaham@bimc.harvard.edu

Locations
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United States, Massachusetts
Alfred Buxton Recruiting
Needham, Massachusetts, United States, 02492
Contact: Alfred Buxton, MD    617-632-9209    abuxton@bidmc.harvard.edu   
Contact: Roger Laham, MD    617-632-7597    rlaham@bidmc.harvard.edu   
Principal Investigator: Alfred E Buxton, MD         
Sub-Investigator: Roger Haham, MD         
Sub-Investigator: Duane Pinto, MD         
Sub-Investigator: Mark Tuttle, MD         
Sub-Investigator: Marie-France Poulin, MD         
Sub-Investigator: Louis Chu, 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         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Alfred Buxton, MD Beth Israel Deaconess Medical Center
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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: July 29, 2021    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Global Results will be published, not individual patient data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Block
Cardiac Conduction System Disease
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Arrhythmias, Cardiac
Pathologic Processes