Aortic StenosisTAVR-HBENCT04982406
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
An observational study of Aortic Stenosis and Transcatheter Aortic Valve Replacement, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, Heart Block
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 409 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 21 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe aortic stenosis or regurgitation planned to undergo transcatheter aortic valve replacement
Who may be able to join
- patients undergoing elective TAVR at BIDMC
Who cannot join
- patients with permanent implanted pacemakers or ICDs prior to TA
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational study, the purpose of which is to:
- Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement.
- Correlate preprocedure ECG features with changes in AV nodal and infranodal conduction during placement of the valve prosthesis.
- Correlate changes in AV nodal and infranodal conduction during the procedure with risk of developing AV conduction block after TAVR.
- 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.
Read the detailed description
Study Population:
Inclusion criteria -all patients undergoing elective TAVR Exclusion criteria -patients with permanent implanted pacemakers or ICDs prior to TAVR
- Record standard 12-lead ECG prior to procedure.
- Place standard electrode catheter via a venous sheath prior to TAVR
- Initially place the catheter in a proximal position with a large atrial electrogram and proximal His electrogram.
- Record baseline His bundle electrogram. Record baseline AH and HV intervals.
- 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.
- 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.
- 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.
- Record presence or absence of retrograde conduction during RV pacing at 4 times pacing threshold.
- Ensure stable continuous His bundle electrogram recording while the aortic valve prosthesis is deployed.
- Use the distal electrodes for rapid ventricular pacing at 4 times threshold during deployment of the valve prosthesis.
- 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.
- Record 12-lead ECG after completion of the procedure and daily thereafter until hospital discharge.
- Standard telemetry monitoring post procedure while hospitalized.
- Upon hospital discharge place a standard continuous ambulatory ECG monitor for 2 weeks in patients that do not have a pacemaker implanted.
- Being tested
- Transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis, Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementDevice
Transcatheter aortic valve replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 30 days following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start18 May 2021
- Primary completion30 Jan 2024
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfred Buxton, Beth Israel Deaconess Medical Center
- Investigators
- Alfred Buxton, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982406
- Sponsor's protocol ID
- 2020P001189
- Acronym
- TAVR-HBE
- Status last verified
- Jan 2025
- First submitted
- 20 Jul 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Global Results will be published, not individual patient data
Publications
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.
PubMed 37737796Medline A, Waks JW, D'Avila A, Tung P, Clarke JR, Poulin MF, Pinto DS, Ultimo B, Kiernan K, Laham RJ, Buxton AE. Electrophysiological observations during and after transcatheter aortic valve replacement. Heart Rhythm. 2026 May 14:S1547-5271(26)02369-6. doi: 10.1016/j.hrthm.2026.05.015. Online ahead of print.
PubMed 42140416
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
- ClinicalTrials.gov ID
- NCT04982406
- Acronym / sponsor ID
- TAVR-HBE / 2020P001189
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study, the purpose of which is to:
- Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement.
- Correlate preprocedure ECG features with changes in AV nodal and infranodal conduction during placement of the valve prosthesis.
- Correlate changes in AV nodal and infranodal conduction during the procedure with risk of developing AV conduction block after TAVR.
- 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.
Detailed description
Study Population:
Inclusion criteria -all patients undergoing elective TAVR Exclusion criteria -patients with permanent implanted pacemakers or ICDs prior to TAVR
- Record standard 12-lead ECG prior to procedure.
- Place standard electrode catheter via a venous sheath prior to TAVR
- Initially place the catheter in a proximal position with a large atrial electrogram and proximal His electrogram.
- Record baseline His bundle electrogram. Record baseline AH and HV intervals.
- 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.
- 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.
- 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.
- Record presence or absence of retrograde conduction during RV pacing at 4 times pacing threshold.
- Ensure stable continuous His bundle electrogram recording while the aortic valve prosthesis is deployed.
- Use the distal electrodes for rapid ventricular pacing at 4 times threshold during deployment of the valve prosthesis.
- 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.
- Record 12-lead ECG after completion of the procedure and daily thereafter until hospital discharge.
- Standard telemetry monitoring post procedure while hospitalized.
- Upon hospital discharge place a standard continuous ambulatory ECG monitor for 2 weeks in patients that do not have a pacemaker implanted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe aortic stenosis or regurgitation planned to undergo transcatheter aortic valve replacement
Key inclusion criteria (1 listed)
- patients undergoing elective TAVR at BIDMC
Key exclusion criteria (1 listed)
- patients with permanent implanted pacemakers or ICDs prior to TA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacementTranscatheter aortic valve replacement | Device | – |
Primary outcome
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..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 37737796Poulin 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.
- Derived from this study: PubMed 42140416Medline A, Waks JW, D'Avila A, Tung P, Clarke JR, Poulin MF, Pinto DS, Ultimo B, Kiernan K, Laham RJ, Buxton AE. Electrophysiological observations during and after transcatheter aortic valve replacement. Heart Rhythm. 2026 May 14:S1547-5271(26)02369-6. doi: 10.1016/j.hrthm.2026.05.015. Online ahead of print.
- Individual participant dataSharing planned: No. Global Results will be published, not individual patient data
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Buxton, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Transcatheter Aortic Valve Replacement, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart block (time frame: 30 days following procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.