Comparing Safety and Effectiveness of His Bundle Pacing Versus Right Ventricular Pacing in Adults with Symptomatic Atrial Fibrillation Undergoing AV Node Ablation and Heart Failure

What this Trial Is About

Atrial fibrillation AF is a common heart rhythm problem, and its occurrence is increasing. Many patients with persistent AF do not respond well to ablation treatments or are not suitable for them due to age, other health issues, or previous unsuccessful procedures. Since controlling heart rhythm does not improve survival compared to rate control, some patients undergo AV node ablation and pacemaker implantation to manage symptoms. This study focuses on comparing a new pacing method called HIS bundle pacing to the standard right ventricular pacing in patients with AF who show signs of heart failure. Participants will be randomly assigned to receive either right ventricular RV pacing or HIS bundle pacing HBP. All will have a pacemaker implanted with a lead in the right ventricle, but only those in the HBP group will have an additional lead on the HIS bundle to stimulate the heart more naturally. AV node ablation will be performed either during the same procedure or within 4-6 weeks. The study uses a double-blind design, with follow-up evaluations at baseline, 4 weeks, 6 months, and 12 months, after which participants and assessors are unblinded. During the year-long study, participants will be monitored for improvements in walking ability, heart function through echocardiograms, heart failure hospitalizations, and pacemaker performance. Activity will be tracked using a Fitbit smartwatch to measure daily steps and walking distance. Safety will be assessed by monitoring for infections, lead problems, and the need for additional procedures. The trial aims to determine if HIS bundle pacing offers advantages over traditional RV pacing for these patients.

Ablate and Pace HIS Study