Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation

NCT ID: NCT05467163

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2026-12-25

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.

Detailed Description

Atrio-ventricular node ablation (AVNA) with subsequent permanent pacemaker implantation provides definite rate control and represents an alternative therapeutic approach in patients with symptomatic atrial fibrillation (AF) and rapid ventricular rate, refractory to optimal medical treatment or catheter ablation. However, optimal pacing modality remains unclear. Previous studies have demonstrated that biventricular (BiV) pacing followed by AVNA resulted in significant reduction in mortality, heart failure (HF) hospitalizations, significant improvement in symptoms and left ventricular (LV) remodeling. Although, its benefit was much less transparent in patients with narrow QRS and LV impairment, as it still causes abnormal cardiac activation with potential worsening of electrical dyssynchrony. To avoid the detrimental effects of BiV pacing a new concept, conduction system pacing (CSP), including His bundle Pacing (HBP) and left bundle branch pacing (LBBP), was proposed as a potential alternative. Both CSP modalities offer advantages over BiV pacing by providing more physiological activation, avoiding cardiac dyssynchrony and left ventricular dysfunction. Moreover, LBBP showed some advantages over HBP. Since the lead is implanted in the region of the left bundle, which has an adequate distance from the AVNA site, this modality could minimize the risk of increase in capture threshold after AVNA. Additionally, the pacing parameters of LBBP were stable in long-term follow-up studies precluding the need for back-up pacing. Therefore compared to HBP and BiV pacing, LBBP may offer a more feasible physiologic pacing option to be adopted into clinical practice. Some observational studies have already shown positive outcomes of HBP and LBBP in symptomatic AF patients who underwent AVNA with the favorable clinical and echocardiographic improvement compared to BIV pacing, especially in HF patients with narrow baseline QRS and reduced ejection fraction (EF<50%). However, prospective randomized study evaluating the value of CSP as an alternative approach to BiV pacing in combination with AVNA is lacking.

The purpose of this study is to compare the effects of CSP and conventional BiV pacing on echocardiographic and clinical outcomes in HF patients with symptomatic AF and narrow QRS scheduled for AVNA. In this multicentric study, 82 patients will be randomized into one of two arms: a BiV pacing arm with BiV pacemaker implantation + AVNA or CSP arm with the implantation of a CSP device + AVNA. In patients randomized in CSP group, LBBP will be the preferred pacing technique. If LBBP will be unobtainable, HBP implantation will be attempted. In both arms additional defibrillator backup will be implanted at the discretion of the physician according to the ESC guidelines. In short-term analysis after 6 months, echocardiographic, laboratory and symptomatic parameters will be evaluated. Long-term analysis to assess HF hospitalization, cardiovascular mortality and pacing parameters will be performed after at least 24 months of follow-up.

Investigators hypothesize that CSP could represent a feasible and safe alternative to BiV pacing in terms of clinical and echocardiographic outcomes.

Conditions

Heart Failure; Tachycardia-induced Cardiomyopathy; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biventricular pacing + AV node ablation

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

Group Type: ACTIVE_COMPARATOR

Biventricular pacemaker implantation

Intervention Type: 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.

AV node ablation

Intervention Type: 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.

Conduction system pacing + AV node ablation

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.

Group Type: EXPERIMENTAL

Conduction system pacing device implantation

Intervention Type: 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.

AV node ablation

Intervention Type: 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.

Interventions

Biventricular pacemaker implantation

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.

Intervention Type: DEVICE

Conduction system pacing device implantation

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.

Intervention Type: DEVICE

AV node ablation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Symptomatic permanent atrial fibrillation, refractory to drug therapy or failed catheter ablation

2. Left ventricular ejection fraction <50%

3. Narrow intrinsic QRS ≤ 120 ms

4. NT-proBNP > 600 ng/L

5. Patient has provided written informed consent

6. Age between 18 years and 85 years

Exclusion Criteria

1. 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.

2. Life expectancy less than 12 months

3. Severe concomitant non-cardiac disease

4. Pregnancy

5. Recent (<3 months) myocardial infarction, percutaneous or surgical myocardial revascularization

6. Significant heart valve disease (severe insufficiency or stenosis)

7. Contraindication for oral anticoagulation

8. Mechanical tricuspid valve replacement

9. Unwillingness to participate or lack of availability for follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

David Žižek, MD, PhD

David Žižek, assist. prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrej Pernat, MD, PhD

Role: STUDY_DIRECTOR

UMC Ljubljana

David Zizek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Ljubljana

Locations

University Hospital Graz - Divison of Cardiology

Graz, , Austria

Site Status: RECRUITING

Hospital Oost-Limburg (Hartzentrum Genk)

Genk, , Belgium

Site Status: RECRUITING

Acibadem City Clinic Tokuda Hospital - Department of Invasive Electrophysiology

Sofia, , Bulgaria

Site Status: RECRUITING

Clinical Hospital Center Rijeka

Rijeka, , Croatia

Site Status: RECRUITING

University Hospital of Split

Split, , Croatia

Site Status: RECRUITING

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status: RECRUITING

Central-Hospital of Northern Pest - Military Hospital

Budapest, , Hungary

Site Status: RECRUITING

County Clinical emergency hospital of Brasov - Department of Interventional Cardiology

Brasov, , Romania

Site Status: RECRUITING

University Medical Centre Ljubljana - Department of cardiology

Ljubljana, , Slovenia

Site Status: RECRUITING

University Medical Centre Ljubljana - Department of cardiovascular surgery

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Austria; Belgium; Bulgaria; Croatia; Hungary; Romania; Slovenia

Central Contacts

David Žižek, MD, PhD

Role: CONTACT

david.zizek@kclj.si

0038615228534

Anja Zupan Mežnar, MD

Role: CONTACT

anja.zupan.meznar@kclj.si

Facility Contacts

Günther Prenner, MD

Role: primary

guenther.prenner@medunigraz.at

Wilfried Mullens, MD, PhD

Role: primary

wilfried.mullens@gmail.com

Vassil Traykov, MD, PhD

Role: primary

vtraykov@yahoo.com

Sandro Brusich, PhD

Role: primary

sandro.brusich@gmail.com

Zrinka Jurišić, MD, PhD

Role: primary

zrinkacn@gmail.com

Borka Pezo Nikolić, MD

Role: primary

borkapezo@yahoo.com

Peter Bogyi, MD, PhD

Role: primary

bogyipeter@gmail.com

+36302821242

Catalin Pestrea, MD, PhD

Role: primary

pestrea.catalin@gmail.com

David Žižek, MD, PhD

Role: primary

david.zizek@kclj.si

0038615228534

Andrej Pernat, MD, PhD

Role: backup

andrej.pernat@kclj.si

0038615228526

Matevz Jan, MD, PhD

Role: primary

matevz.jan@kclj.si

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Other Identifiers

CONDUCT-AF trial

Identifier Type: -

Identifier Source: org_study_id