RecruitingNot ApplicableNCT05467163

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)

Sponsor

University Medical Centre Ljubljana

Enrollment

82 participants

Start Date

Jul 18, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation Tachycardia-induced Cardiomyopathy

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of heart pacing devices for people with irregular heart rhythms (atrial fibrillation) and a weakened heart. One method uses a newer "conduction system pacing" technique, and the other uses the traditional biventricular pacing. **You may be eligible if...** - You have permanent atrial fibrillation (an irregular, fast heartbeat) that has not responded to medication or catheter procedures - Your heart's pumping function (ejection fraction) is below 50% - Your natural heartbeat signal is relatively narrow (QRS ≤ 120 ms on an ECG) - You are between 18 and 85 years old **You may NOT be eligible if...** - You already have a permanent pacemaker or defibrillator implanted (with some exceptions) - Your life expectancy is less than 12 months - You have had a heart attack or heart procedure in the past 3 months - You have severe heart valve disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEBiventricular 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.

DEVICEConduction 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.

PROCEDUREAV 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.