Outcomes and Safety of Various Conduction System Pacing Methods

NCT04749836 | Unknown DMC

• 1 other identifier: Conduction pacing Registry
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AV Block; Bundle-Branch Block; Atrial Fibrillation Rapid

Keywords

His bundle pacing; Left bundle branch area pacing; Bachmann bundle pacing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Pacing parameters

  peri-procedural

• Stepwise approach of pacing modes

  peri-procedural

• Pacing lead stability

  through study completion, an average of 2 years

• Heart failure hospitalisation

  through study completion, an average of 2 years

• Echocardiographic measurements

  through study completion, an average of 1 year

Interventions

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.

Eligibility Criteria

• Age: 5 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers with pacing indication as described in eligibility criteria.

You may qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana - Cardiology department

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (14)

• 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.

  PMID: 27773407 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.

  PMID: 16051118 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.

  PMID: 15828875 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.

  PMID: 28641799 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.

  PMID: 30649270 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.

  PMID: 27151347 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.

  PMID: 27553893 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.

  PMID: 31249403 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.

  PMID: 30115232 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.

  PMID: 31310403 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.

  PMID: 30192005 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.

  PMID: 31456266 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.

  PMID: 27457727 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.

  PMID: 32681681 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Žižek, Assist. Prof.

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Žižek, Assist. Prof.

CONTACT

+38615228534; david.zizek@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of electro-stimulation program

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 11, 2021
• Study Start: February 4, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

SL (1)