Prospective Randomized Controlled Clinical Study of Physiological Ventricular Rhythm Resetting in Patients with Atrial Fibrillation and Heart Failure: Rationale and Design

Background Atrial fibrillation (AF) and heart failure (HF) frequently co-exist. HF may present in 20-30% of AF patients. Both AF and HF facilitate the occurrence and aggravate the prognosis of each other, which significantly affects the quality of life and increases mortality. This paper describes the rationale and the design of the trial 'Prospective randomized controlled clinical study of physiological ventricular rhythm resetting in patients with atrial fibrillation and heart failure' and the need to improve the treatment of the patients with AF and HF. Methods This study is a registry-based, prospective, randomized, parallel, single-center trial. The primary aim is to determine whether the physiological ventricular rhythm resetting (atrioventricular node ablation with physiological LBBP) can improve clinical outcomes (all-cause mortality or rehospitalization for HF) compared with medical rate control. A total of 110 patients will be enrolled in the trial and followed up for 1 year. Summary The cardioversion of AF is a major treatment for AF patients with HF. However, the recurrence rate of atrial fibrillation ablation is high and part of these patients are not suitable for ablation, which raised the difficulty to treat such patients. Some observational studies found that AVNA with physiological pacing could improve the prognosis of these patients. Thus, results from this trial may influence future treatment strategies and guidelines specific to AF patients with HF.