Study of Heart Rate Regularization Using Atrioventricular Node Ablation and Physiological Pacing in Patients With Well Controlled Permanent Atrial Fibrillation and Heart Failure with Preserved Ejection Fraction

What this Trial Is About

Researchers are evaluating the clinical effectiveness of combining physiological pacing with atrioventricular node ablation in patients who have heart failure with preserved ejection fraction HFpEF and well-controlled permanent atrial fibrillation. The study aims to determine if this combination can reduce mortality and hospitalizations for heart failure compared to standard drug therapy. This research focuses on heart rate regularization to prevent the harmful effects of right ventricular apical pacing in this patient group. Participants will be randomly assigned to one of two groups the intervention group receiving pacemaker implantation and atrioventricular node ablation, or the control group receiving optimized drug therapy. The pacemaker will be programmed in VVIR mode with a set lower rate. Procedures will occur within one week after randomization, and drug therapies will be adjusted according to current guidelines in both groups. During the study, participants will visit the clinic at 3, 12, and 24 months after randomization for checkups and tests. Researchers will monitor time to the combined outcome of death, heart failure hospitalizations, or use of intravenous diuretics over 24 months. Secondary measures include changes in heart function scores, biomarker levels, and adverse events related to the procedures. The total follow-up period is 24 months.

Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization Versus Medical Rate Control