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The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and long-term implant success rate | Ventricular activation occurring over the conduction system with acceptable pacing threshold | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pacing parameters | Capture threshold, R waves, lead impedance, QRS morphology | peri-procedural |
| Stepwise approach of pacing modes | Proportion of patients with HBP as a first option and LBBA as a fist option |
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Inclusion Criteria:
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All comers with pacing indication as described in eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Žižek, Assist. Prof. | Contact | +38615228534 | david.zizek@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| David Žižek, Assist. Prof. | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana - Cardiology department | Recruiting | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27773407 | Background | 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. | |
| 16051118 | Background | Sharma 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. |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| peri-procedural |
| Pacing lead stability | Lead threshold fluctuation | through study completion, an average of 2 years |
| Heart failure hospitalisation | Incidence of heart failure hospitalizations after device implantation | through study completion, an average of 2 years |
| Echocardiographic measurements | Assessment of cardiac function | through study completion, an average of 1 year |
| Procedural characteristics | Total procedure and fluoroscopy time in minutes | peri-procedural |
| 15828875 | Background | Steinberg 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. |
| 28641799 | Background | Vijayaraman 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. |
| 30649270 | Background | Boriani 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. |
| 27151347 | Background | Curtis 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. |
| 27553893 | Background | Beck 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. |
| 31249403 | Background | Sharma 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. |
| 30115232 | Background | Vijayaraman 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. |
| 31310403 | Background | Keene 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. |
| 30192005 | Background | Jastrzebski 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. |
| 31456266 | Background | Gu 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. |
| 27457727 | Background | Vijayaraman 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. |
| 32681681 | Background | Ponnusamy 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |