AV BlockNCT04749836
Outcomes and Safety of Various Conduction System Pacing Methods
An observational study of AV Block and Bundle-Branch Block, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry. Read more about this study
- Who is it for?
- Ages 5 to 85 years
- Conditions the study is for
- AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid
- What is being tested?
- His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSlovenia
- Study dates
- 4 Feb 2021to 1 Dec 2024
- How long will I take part?
- 2 Years
- 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 5 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All comers with pacing indication as described in eligibility criteria.
Who may be able to join
- Class I and II indications for permanent pacing
- Atrial fibrillation with uncontrolled ventricular rate for pace and ablate strategy
- Bundle branch block correction for HF patients
- Patients with prolonged PR interval and dromotropathy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana - Cardiology department
Ljubljana, 1000
David Žižek, david.zizek@kclj.si
About this study
Official title: Registry of His Bundle, Bachmann Bundle and Left Bundle Branch Area Pacing for Various Pacing Indications
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
Read the detailed description
In comparison with right ventricular pacing-induced electromechanical dyssynchrony, conduction system pacing is providing physiological pacing via His-Purkinje activation. Current approaches include His bundle (HBP), left bundle branch area pacing (LBBAP), and Bachmann bundle pacing. In addition, HBP and LBBAP enable correction of underlying proximal bundle branch block, consequently improving the ventricular activation time and narrowing the QRS. Furthermore, atrial activation can be improved with direct Bachmann bundle stimulation. However, the data regarding long-term performance and safety of these physiological approaches in various clinical scenarios is scarce.
With this registry, the investigators would like to obtain real-world data regarding the feasibility and safety of this physiological pacing approaches in various pacing indications and their implementation in routine clinical practice.
Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, 1-3 months after inclusion and every 6 months thereafter. Minimal follow-up will be 2 years.
- Conditions
- AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid
- Being tested
- His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing
- Keywords
- His bundle pacing, Left bundle branch area pacing, Bachmann bundle pacing
- Medical subject headings
- Atrioventricular Block, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacingProcedure or surgery
Different active fixation leads and the dedicated delivery sheaths are introduced via standard transvenous approach under fluoroscopic guidance. His bundle potential mapping is performed in a unipolar setting with the use of the electrophysiological system for His bundle pacing. After localizing the His bundle potential, the pacing is attempted before the lead fixation to confirm HB capture. The lead is then screwed into position. Acute HBP threshold ≤ 2.5V at 1ms is considered acceptable. On the other hand, the initial site for LBBP is approximately 1-1.5 cm distal to the HBP lead position in the RV septum along the line between the HBP site and RV apex in the right anterior oblique (30°) fluoroscopic view. Bachmann bundle pacing (upper atrial septum) will be performed with the J-stylet modification technique or with specialized catheter method using the SelectSecure active fixation lead.
Stepwise approach for conduction pacing will also be tested.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and long-term implant success rate
Ventricular activation occurring over the conduction system with acceptable pacing threshold
Measured: through study completion, an average of 2 years
Secondary outcomes (6)
Pacing parameters
Capture threshold, R waves, lead impedance, QRS morphology
Measured: peri-procedural
Stepwise approach of pacing modes
Proportion of patients with HBP as a first option and LBBA as a fist option
Measured: peri-procedural
Pacing lead stability
Lead threshold fluctuation
Measured: through study completion, an average of 2 years
Heart failure hospitalisation
Incidence of heart failure hospitalizations after device implantation
Measured: through study completion, an average of 2 years
Echocardiographic measurements
Assessment of cardiac function
Measured: through study completion, an average of 1 year
Procedural characteristics
Total procedure and fluoroscopy time in minutes
Measured: peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start4 Feb 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AV BlockStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Žižek, MD, PhD, University Medical Centre Ljubljana
- Investigators
- David Žižek, Assist. Prof., Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749836
- Sponsor's protocol ID
- Conduction pacing Registry
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Das A, Banerjee S, Mandal SC. A simple method for Bachmann's bundle pacing with indigenous modification of J-stylet. Indian Heart J. 2016 Sep-Oct;68(5):678-684. doi: 10.1016/j.ihj.2015.10.299. Epub 2016 Jan 11.
PubMed 27773407Sharma AD, Rizo-Patron C, Hallstrom AP, O'Neill GP, Rothbart S, Martins JB, Roelke M, Steinberg JS, Greene HL; DAVID Investigators. Percent right ventricular pacing predicts outcomes in the DAVID trial. Heart Rhythm. 2005 Aug;2(8):830-4. doi: 10.1016/j.hrthm.2005.05.015.
PubMed 16051118Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ; MADIT II Investigators. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 Apr;16(4):359-65. doi: 10.1046/j.1540-8167.2005.50038.x.
PubMed 15828875Vijayaraman P, Bordachar P, Ellenbogen KA. The Continued Search for Physiological Pacing: Where Are We Now? J Am Coll Cardiol. 2017 Jun 27;69(25):3099-3114. doi: 10.1016/j.jacc.2017.05.005.
PubMed 28641799Boriani G, Pieragnoli P, Botto GL, Puererfellner H, Mont L, Ziacchi M, Manolis AS, Gulizia M, Tukkie R, Landolina M, Ricciardi G, Cicconelli M, Grammatico A, Biffi M. Effect of PR interval and pacing mode on persistent atrial fibrillation incidence in dual chamber pacemaker patients: a sub-study of the international randomized MINERVA trial. Europace. 2019 Apr 1;21(4):636-644. doi: 10.1093/europace/euy286.
PubMed 30649270Curtis AB, Worley SJ, Chung ES, Li P, Christman SA, St John Sutton M. Improvement in Clinical Outcomes With Biventricular Versus Right Ventricular Pacing: The BLOCK HF Study. J Am Coll Cardiol. 2016 May 10;67(18):2148-2157. doi: 10.1016/j.jacc.2016.02.051.
PubMed 27151347Beck H, Curtis AB. Right Ventricular Versus Biventricular Pacing for Heart Failure and Atrioventricular Block. Curr Heart Fail Rep. 2016 Oct;13(5):230-236. doi: 10.1007/s11897-016-0299-3.
PubMed 27553893Sharma PS, Vijayaraman P, Ellenbogen KA. Permanent His bundle pacing: shaping the future of physiological ventricular pacing. Nat Rev Cardiol. 2020 Jan;17(1):22-36. doi: 10.1038/s41569-019-0224-z. Epub 2019 Jun 27.
PubMed 31249403Vijayaraman P, Chung MK, Dandamudi G, Upadhyay GA, Krishnan K, Crossley G, Bova Campbell K, Lee BK, Refaat MM, Saksena S, Fisher JD, Lakkireddy D; ACC's Electrophysiology Council. His Bundle Pacing. J Am Coll Cardiol. 2018 Aug 21;72(8):927-947. doi: 10.1016/j.jacc.2018.06.017.
PubMed 30115232Keene D, Arnold AD, Jastrzebski M, Burri H, Zweibel S, Crespo E, Chandrasekaran B, Bassi S, Joghetaei N, Swift M, Moskal P, Francis DP, Foley P, Shun-Shin MJ, Whinnett ZI. His bundle pacing, learning curve, procedure characteristics, safety, and feasibility: Insights from a large international observational study. J Cardiovasc Electrophysiol. 2019 Oct;30(10):1984-1993. doi: 10.1111/jce.14064. Epub 2019 Aug 2.
PubMed 31310403Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Czarnecka D. His-bundle pacing as a standard approach in patients with permanent atrial fibrillation and bradycardia. Pacing Clin Electrophysiol. 2018 Nov;41(11):1508-1512. doi: 10.1111/pace.13490. Epub 2018 Sep 19.
PubMed 30192005Gu M, Hu Y, Hua W, Niu H, Chen X, Cai M, Zhang N, Li H, Zhou X, Zhang S. Visualization of tricuspid valve annulus for implantation of His bundle pacing in patients with symptomatic bradycardia. J Cardiovasc Electrophysiol. 2019 Oct;30(10):2164-2169. doi: 10.1111/jce.14140. Epub 2019 Aug 31.
PubMed 31456266Vijayaraman P, Dandamudi G. Anatomical approach to permanent His bundle pacing: Optimizing His bundle capture. J Electrocardiol. 2016 Sep-Oct;49(5):649-57. doi: 10.1016/j.jelectrocard.2016.07.003. Epub 2016 Jul 11.
PubMed 27457727Ponnusamy SS, Arora V, Namboodiri N, Kumar V, Kapoor A, Vijayaraman P. Left bundle branch pacing: A comprehensive review. J Cardiovasc Electrophysiol. 2020 Sep;31(9):2462-2473. doi: 10.1111/jce.14681. Epub 2020 Jul 30.
PubMed 32681681
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of His Bundle, Bachmann Bundle and Left Bundle Branch Area Pacing for Various Pacing Indications
- ClinicalTrials.gov ID
- NCT04749836
- Acronym / sponsor ID
- Conduction pacing Registry
- Conditions
- AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid
- Keywords
- His bundle pacing, Left bundle branch area pacing, Bachmann bundle pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Feb 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.
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
Detailed description
In comparison with right ventricular pacing-induced electromechanical dyssynchrony, conduction system pacing is providing physiological pacing via His-Purkinje activation. Current approaches include His bundle (HBP), left bundle branch area pacing (LBBAP), and Bachmann bundle pacing. In addition, HBP and LBBAP enable correction of underlying proximal bundle branch block, consequently improving the ventricular activation time and narrowing the QRS. Furthermore, atrial activation can be improved with direct Bachmann bundle stimulation. However, the data regarding long-term performance and safety of these physiological approaches in various clinical scenarios is scarce.
With this registry, the investigators would like to obtain real-world data regarding the feasibility and safety of this physiological pacing approaches in various pacing indications and their implementation in routine clinical practice.
Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, 1-3 months after inclusion and every 6 months thereafter. Minimal follow-up will be 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All comers with pacing indication as described in eligibility criteria.
Key inclusion criteria (4 listed)
- Class I and II indications for permanent pacing
- Atrial fibrillation with uncontrolled ventricular rate for pace and ablate strategy
- Bundle branch block correction for HF patients
- Patients with prolonged PR interval and dromotropathy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacingDifferent active fixation leads and the dedicated delivery sheaths are introduced via standard transvenous approach under fluoroscopic guidance. His bundle potential mapping is performed in a unipolar setting with the use of the electrophysiological system for His bundle pacing. After localizing the His bundle potential, the pacing is attempted before the lead fixation to confirm HB capture. The lead is then screwed into position. Acute HBP threshold ≤ 2.5V at 1ms is considered acceptable. On the other hand, the initial site for LBBP is approximately 1-1.5 cm distal to the HBP lead position in the RV septum along the line between the HBP site and RV apex in the right anterior oblique (30°) fluoroscopic view. Bachmann bundle pacing (upper atrial septum) will be performed with the J-stylet modification technique or with specialized catheter method using the SelectSecure active fixation lead. Stepwise approach for conduction pacing will also be tested. | Procedure or surgery | – |
Primary outcome
Acute and long-term implant success rate
Time frame: through study completion, an average of 2 years
Ventricular activation occurring over the conduction system with acceptable pacing threshold
6 secondary outcomes
Pacing parameters
Time frame: peri-procedural
Stepwise approach of pacing modes
Time frame: peri-procedural
Pacing lead stability
Time frame: through study completion, an average of 2 years
Heart failure hospitalisation
Time frame: through study completion, an average of 2 years
Echocardiographic measurements
Time frame: through study completion, an average of 1 year
Procedural characteristics
Time frame: peri-procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 27773407Das A, Banerjee S, Mandal SC. A simple method for Bachmann's bundle pacing with indigenous modification of J-stylet. Indian Heart J. 2016 Sep-Oct;68(5):678-684. doi: 10.1016/j.ihj.2015.10.299. Epub 2016 Jan 11.
- Background: PubMed 16051118Sharma AD, Rizo-Patron C, Hallstrom AP, O'Neill GP, Rothbart S, Martins JB, Roelke M, Steinberg JS, Greene HL; DAVID Investigators. Percent right ventricular pacing predicts outcomes in the DAVID trial. Heart Rhythm. 2005 Aug;2(8):830-4. doi: 10.1016/j.hrthm.2005.05.015.
- Background: PubMed 15828875Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ; MADIT II Investigators. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 Apr;16(4):359-65. doi: 10.1046/j.1540-8167.2005.50038.x.
- Background: PubMed 28641799Vijayaraman P, Bordachar P, Ellenbogen KA. The Continued Search for Physiological Pacing: Where Are We Now? J Am Coll Cardiol. 2017 Jun 27;69(25):3099-3114. doi: 10.1016/j.jacc.2017.05.005.
- Background: PubMed 30649270Boriani G, Pieragnoli P, Botto GL, Puererfellner H, Mont L, Ziacchi M, Manolis AS, Gulizia M, Tukkie R, Landolina M, Ricciardi G, Cicconelli M, Grammatico A, Biffi M. Effect of PR interval and pacing mode on persistent atrial fibrillation incidence in dual chamber pacemaker patients: a sub-study of the international randomized MINERVA trial. Europace. 2019 Apr 1;21(4):636-644. doi: 10.1093/europace/euy286.
- Background: PubMed 27151347Curtis AB, Worley SJ, Chung ES, Li P, Christman SA, St John Sutton M. Improvement in Clinical Outcomes With Biventricular Versus Right Ventricular Pacing: The BLOCK HF Study. J Am Coll Cardiol. 2016 May 10;67(18):2148-2157. doi: 10.1016/j.jacc.2016.02.051.
- Background: PubMed 27553893Beck H, Curtis AB. Right Ventricular Versus Biventricular Pacing for Heart Failure and Atrioventricular Block. Curr Heart Fail Rep. 2016 Oct;13(5):230-236. doi: 10.1007/s11897-016-0299-3.
- Background: PubMed 31249403Sharma PS, Vijayaraman P, Ellenbogen KA. Permanent His bundle pacing: shaping the future of physiological ventricular pacing. Nat Rev Cardiol. 2020 Jan;17(1):22-36. doi: 10.1038/s41569-019-0224-z. Epub 2019 Jun 27.
- Background: PubMed 30115232Vijayaraman P, Chung MK, Dandamudi G, Upadhyay GA, Krishnan K, Crossley G, Bova Campbell K, Lee BK, Refaat MM, Saksena S, Fisher JD, Lakkireddy D; ACC's Electrophysiology Council. His Bundle Pacing. J Am Coll Cardiol. 2018 Aug 21;72(8):927-947. doi: 10.1016/j.jacc.2018.06.017.
- Background: PubMed 31310403Keene D, Arnold AD, Jastrzebski M, Burri H, Zweibel S, Crespo E, Chandrasekaran B, Bassi S, Joghetaei N, Swift M, Moskal P, Francis DP, Foley P, Shun-Shin MJ, Whinnett ZI. His bundle pacing, learning curve, procedure characteristics, safety, and feasibility: Insights from a large international observational study. J Cardiovasc Electrophysiol. 2019 Oct;30(10):1984-1993. doi: 10.1111/jce.14064. Epub 2019 Aug 2.
- Background: PubMed 30192005Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Czarnecka D. His-bundle pacing as a standard approach in patients with permanent atrial fibrillation and bradycardia. Pacing Clin Electrophysiol. 2018 Nov;41(11):1508-1512. doi: 10.1111/pace.13490. Epub 2018 Sep 19.
- Background: PubMed 31456266Gu M, Hu Y, Hua W, Niu H, Chen X, Cai M, Zhang N, Li H, Zhou X, Zhang S. Visualization of tricuspid valve annulus for implantation of His bundle pacing in patients with symptomatic bradycardia. J Cardiovasc Electrophysiol. 2019 Oct;30(10):2164-2169. doi: 10.1111/jce.14140. Epub 2019 Aug 31.
- Individual participant dataSharing planned: Undecided
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AV Block
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.
David Žižek, Assist. Prof. principal investigator
University Medical Centre Ljubljana
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 AV Block and Bundle-Branch Block, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Žižek, Assist. Prof. (+38615228534, david.zizek@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and long-term implant success rate (time frame: through study completion, an average of 2 years). 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 NCT04749836, which also lists 14 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 9 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.