Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation

NCT05467163 | Active Not Recruiting DMC

• 1 other identifier: CONDUCT-AF trial
• Study Type: interventional
• Target: 82
• Locations: 7 countries
• Sites: 10

Brief Summary

Atrioventricular node ablation (AVNA) with biventricular (BiV) pacemaker implantation is a feasible treatment option in patients with symptomatic refractory atrial fibrillation and heart failure. However, conduction system pacing (CSP) modalities, including His bundle pacing and left bundle branch pacing, could offer advantages over BiV pacing by providing more physiological activation. The randomized, interventional, multicentric study will explore whether CSP is non-inferior to BiV pacing in echocardiographic and clinical outcomes in heart failure (EF \<50%) patients with symptomatic AF and narrow QRS scheduled for AVNA.

Conditions

Heart Failure; Tachycardia-induced Cardiomyopathy; Atrial Fibrillation

Keywords

Heart failure; Atrial fibrillation; Conduction system pacing; His bundle pacing; Left bundle branch pacing; Biventricular pacing; Atrioventricular node ablation

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction.

  Simpson's method assessed with echo.

  baseline and 6 months

Secondary Outcomes (16)

• Time to the first occurrence of worsening heart failure or cardiovascular death.

  at least 24 months

• Time to the first occurrence of worsening heart failure.

  at least 24 months

• Time to cardiovascular death.

  at least 24 months

• Number of heart failure hospitalizations.

  at least 24 months

• Change in LV end-diastolic and end-systolic volume index.

  baseline and 6 months

Study Arms (2)

Biventricular pacing + AV node ablation

ACTIVE COMPARATOR

Implantation of biventricular pacemaker with or without defibrillator lead placement followed by AV node ablation. Optimal guidelines-based heart failure treatment.

Device: Biventricular pacemaker implantation; Procedure: AV node ablation

Conduction system pacing + AV node ablation

EXPERIMENTAL

Implantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement followed by AV node ablation. Optimal guidelines-based heart failure treatment.

Device: Conduction system pacing device implantation; Procedure: AV node ablation

Interventions

Biventricular pacemaker implantation DEVICE

Implantation of permanent pacemaker with biventricular stimulation with or without defibrillator lead placement using standard techniques. The right ventricle lead will be positioned in the RV apex or septum, while the left ventricle lead will be delivered to the most appropriate coronary sinus tributary, preferably posterolateral or lateral vein.

Biventricular pacing + AV node ablation

Conduction system pacing device implantation DEVICE

Left bundle branch pacing (LBBP) will be the preferred pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory. If LBBP will be unobtainable, His bundle pacing (HBP) implantation will be attempted. His bundle potential mapping will be performed with the use of the electrophysiological system and under fluoroscopic guidance. Distal HB potential with a large ventricular signal and a small atrial signal will be targeted before the pacing lead will be screwed into position. Backup RV lead will be mandatory for all patients receiving HBP devices.

Conduction system pacing + AV node ablation

AV node ablation PROCEDURE

Atrioventricular node ablation (AVNA) will be performed following pacemaker implantation (preferably during the same hospitalization). After femoral vein access will be obtained, the ablation catheter will be positioned to the presumed area of the AV node in the mid-septum under fluoroscopy. The location will be optimized according to the intracardiac electrograms. Ablation will be performed in a temperature-controlled mode. Successful AVNA will be recognized with an abrupt drop of heart rate to 40 bpm and will continue for 60 seconds thereafter.

Biventricular pacing + AV node ablation; Conduction system pacing + AV node ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic permanent atrial fibrillation, refractory to drug therapy or failed catheter ablation
• Left ventricular ejection fraction \<50%
• Narrow intrinsic QRS ≤ 120 ms
• NT-proBNP \> 600 ng/L
• Patient has provided written informed consent
• Age between 18 years and 85 years

You may not qualify if:

• Pre-existing permanent pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization device. Patients who had devices implanted that had \<5% of paced beats (i.e., backup pacing) can be enrolled.
• Life expectancy less than 12 months
• Severe concomitant non-cardiac disease
• Pregnancy
• Recent (\<3 months) myocardial infarction, percutaneous or surgical myocardial revascularization
• Significant heart valve disease (severe insufficiency or stenosis)
• Contraindication for oral anticoagulation
• Mechanical tricuspid valve replacement
• Unwillingness to participate or lack of availability for follow-up

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (10)

University Hospital Graz - Divison of Cardiology

Graz, Austria

Location

Hospital Oost-Limburg (Hartzentrum Genk)

Genk, Belgium

Location

Acibadem City Clinic Tokuda Hospital - Department of Invasive Electrophysiology

Sofia, Bulgaria

Location

Clinical Hospital Center Rijeka

Rijeka, Croatia

Location

University Hospital of Split

Split, Croatia

Location

University Hospital Centre Zagreb

Zagreb, Croatia

Location

Central-Hospital of Northern Pest - Military Hospital

Budapest, 1134, Hungary

Location

County Clinical emergency hospital of Brasov - Department of Interventional Cardiology

Brasov, Romania

Location

University Medical Centre Ljubljana - Department of cardiology

Ljubljana, 1000, Slovenia

Location

University Medical Centre Ljubljana - Department of cardiovascular surgery

Ljubljana, 1000, Slovenia

Location

Related Publications (12)

• Tan ES, Rienstra M, Wiesfeld AC, Schoonderwoerd BA, Hobbel HH, Van Gelder IC. Long-term outcome of the atrioventricular node ablation and pacemaker implantation for symptomatic refractory atrial fibrillation. Europace. 2008 Apr;10(4):412-8. doi: 10.1093/europace/eun020. Epub 2008 Feb 12.

  PMID: 18272509 BACKGROUND

• Orlov MV, Gardin JM, Slawsky M, Bess RL, Cohen G, Bailey W, Plumb V, Flathmann H, de Metz K. Biventricular pacing improves cardiac function and prevents further left atrial remodeling in patients with symptomatic atrial fibrillation after atrioventricular node ablation. Am Heart J. 2010 Feb;159(2):264-70. doi: 10.1016/j.ahj.2009.11.012.

  PMID: 20152225 BACKGROUND

• Chatterjee NA, Upadhyay GA, Ellenbogen KA, Hayes DL, Singh JP. Atrioventricular nodal ablation in atrial fibrillation: a meta-analysis of biventricular vs. right ventricular pacing mode. Eur J Heart Fail. 2012 Jun;14(6):661-7. doi: 10.1093/eurjhf/hfs036. Epub 2012 Mar 21.

  PMID: 22436544 BACKGROUND

• Brignole M, Pentimalli F, Palmisano P, Landolina M, Quartieri F, Occhetta E, Calo L, Mascia G, Mont L, Vernooy K, van Dijk V, Allaart C, Fauchier L, Gasparini M, Parati G, Soranna D, Rienstra M, Van Gelder IC; APAF-CRT Trial Investigators. AV junction ablation and cardiac resynchronization for patients with permanent atrial fibrillation and narrow QRS: the APAF-CRT mortality trial. Eur Heart J. 2021 Dec 7;42(46):4731-4739. doi: 10.1093/eurheartj/ehab569.

  PMID: 34453840 BACKGROUND

• Muthumala A, Vijayaraman P. His-Purkinje conduction system pacing and atrioventricular node ablation. Herzschrittmacherther Elektrophysiol. 2020 Jun;31(2):117-123. doi: 10.1007/s00399-020-00679-7. Epub 2020 May 6.

  PMID: 32377902 BACKGROUND

• Wang S, Wu S, Xu L, Xiao F, Whinnett ZI, Vijayaraman P, Su L, Huang W. Feasibility and Efficacy of His Bundle Pacing or Left Bundle Pacing Combined With Atrioventricular Node Ablation in Patients With Persistent Atrial Fibrillation and Implantable Cardioverter-Defibrillator Therapy. J Am Heart Assoc. 2019 Dec 17;8(24):e014253. doi: 10.1161/JAHA.119.014253. Epub 2019 Dec 13.

  PMID: 31830874 BACKGROUND

• Su L, Cai M, Wu S, Wang S, Xu T, Vijayaraman P, Huang W. Long-term performance and risk factors analysis after permanent His-bundle pacing and atrioventricular node ablation in patients with atrial fibrillation and heart failure. Europace. 2020 Dec 26;22(Suppl_2):ii19-ii26. doi: 10.1093/europace/euaa306.

  PMID: 33370800 BACKGROUND

• Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. Benefits of Permanent His Bundle Pacing Combined With Atrioventricular Node Ablation in Atrial Fibrillation Patients With Heart Failure With Both Preserved and Reduced Left Ventricular Ejection Fraction. J Am Heart Assoc. 2017 Apr 1;6(4):e005309. doi: 10.1161/JAHA.116.005309.

  PMID: 28365568 BACKGROUND

• Zizek D, Antolic B, Meznar AZ, Zavrl-Dzananovic D, Jan M, Stublar J, Pernat A. Biventricular versus His bundle pacing after atrioventricular node ablation in heart failure patients with narrow QRS. Acta Cardiol. 2022 May;77(3):222-230. doi: 10.1080/00015385.2021.1903196. Epub 2021 Jun 2.

  PMID: 34078244 BACKGROUND

• Ivanovski M, Mrak M, Meznar AZ, Zizek D. Biventricular versus Conduction System Pacing after Atrioventricular Node Ablation in Heart Failure Patients with Atrial Fibrillation. J Cardiovasc Dev Dis. 2022 Jul 1;9(7):209. doi: 10.3390/jcdd9070209.

  PMID: 35877570 BACKGROUND

• Pillai A, Kolominsky J, Koneru JN, Kron J, Shepard RK, Kalahasty G, Huang W, Verma A, Ellenbogen KA. Atrioventricular junction ablation in patients with conduction system pacing leads: A comparison of His-bundle vs left bundle branch area pacing leads. Heart Rhythm. 2022 Jul;19(7):1116-1123. doi: 10.1016/j.hrthm.2022.03.1222. Epub 2022 Mar 26.

  PMID: 35351624 BACKGROUND

• Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.

  PMID: 31504425 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrej Pernat, MD, PhD

  UMC Ljubljana

  STUDY DIRECTOR

• David Zizek, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Žižek, assist. prof.

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 20, 2022
• Study Start: July 18, 2023
• Primary Completion: December 25, 2025
• Study Completion (Estimated): December 25, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); RO (1); CR (3); HU (1); SL (2); AU (1); BU (1)