RECRUITINGINTERVENTIONAL

Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation

CONDUCTion System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation in Heart Failure Patients With Symptomatic Atrial Fibrillation and Narrow QRS (CONDUCT-AF Trial)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 6. Age between 18 years and 85 years Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

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.

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.

PROCEDURE

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.

Locations (10)

University Hospital Graz - Divison of Cardiology

Graz, Austria

Hospital Oost-Limburg (Hartzentrum Genk)

Genk, Belgium

Acibadem City Clinic Tokuda Hospital - Department of Invasive Electrophysiology

Sofia, Bulgaria

Clinical Hospital Center Rijeka

Rijeka, Croatia

University Hospital of Split

Split, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Central-Hospital of Northern Pest - Military Hospital

Budapest, Hungary

County Clinical emergency hospital of Brasov - Department of Interventional Cardiology

Brasov, Romania

University Medical Centre Ljubljana - Department of cardiology

Ljubljana, Slovenia

University Medical Centre Ljubljana - Department of cardiovascular surgery

Ljubljana, Slovenia