A multicenter study comparing the outcome of catheter ablation of atrial fibrillation between cryoballoon and radiofrequency ablation in patients with heart failure (CRABL‐HF): Study design

Abstract

Background: Catheter ablation of atrial fibrillation (AF) is increasingly performed worldwide in patients with heart failure (HF). However, it has been recently emphasized that AF ablation in patients with HF is associated with increased risks of procedure-related complications and mortality. There are little data about the differences in the efficacy and safety between cryoballoon (CB) and radiofrequency (RF) ablation of AF in patients with HF. Methods:The CRABL-HF study is designed as a prospective, multicenter, open-label, controlled, and randomized clinical trial comparing the efficacy and safety of AF ablation between CB and RF ablation in patients with HF (LVEF ≤40%) (UMIN Clinical Trials Registry UMIN000032433). The CRABL-HF study will consist of 110 patients at multicenter in Japan. The patients will be registered and randomly assigned to either the CB ablation or RF ablation group with a 1:1 allocation. The primary endpoint of this study is the occurrence of atrial tachyarrhythmias (ATs) at 1 year with a blanking period of 90 days after ablation. Key secondary endpoints are the success rate of the pulmonary vein isolation, total procedural time, left atrial dwelling time, total fluoroscopy time, radiation exposure, complication rate, composite of all-cause mortality or HF hospitalizations, cardiovascular events, change in left ventricular ejection fraction, and change in quality of life. Results:The results of this study are currently under investigation. Conclusion:The CRABL-HF study is being conducted to compare the efficacy and safety of catheter ablation of AF between CB and RF ablation in patients with HF.

Efficacy and feasibility of cryoballoon ablation for atrial fibrillation in patients with heart failure: A large‐scale multicenter study

“…Nonetheless, the 1‐year recurrence‐free rate in our study was not remarkably different from those of previous studies of similar populations, 10,11 indicating that the follow‐up protocols adopted by our study institutions were not unusual. The study did not include non‐HF patients undergoing cryoballoon ablation or a comparable group of those HF patients undergoing radiofrequency ablation for AF or a medication‐only group 23,24 . The study did not assess symptom recovery, NYHA class, or quality of life after the follow‐up period 11 .…”

“…The majority of included patients had preserved or only mildly decreased LVEF, and therefore, this was predominantly a study of patients with HFpEF. A future study of cryoballoon ablation targeting a large number of patients with a reduced LVEF (≤40%) is warranted 23 . Some patients were lost to follow‐up soon after the ablation or lacked BNP level or echocardiography data during follow‐up.…”

“…The study did not include non-HF patients undergoing cryoballoon ablation or a comparable group of those HF patients undergoing radiofrequency ablation for AF or a medication-only group. 23,24 The study did not assess symptom recovery, NYHA class, or quality of life after the follow-up period. 11 The LVEF groups of HF patients were stratified based on the LVEF determined on echocardiography before the procedure time, and the value of LVEF might have changed according to recent HF onset and management thereafter.…”

“…A future study of cryoballoon ablation targeting a large number of patients with a reduced LVEF (≤40%) is warranted. 23 Some patients were lost to follow-up soon after the ablation or lacked BNP level or echocardiography data during follow-up. The heterogeneity of the follow-up schedule, examination assessments of recurrence, and treatment options among institutions might have been substantial and could have affected the outcomes.…”

A multicenter prospective randomized study comparing the incidence of periprocedural cerebral embolisms caused by catheter ablation of atrial fibrillation between cryoballoon and radiofrequency ablation (Embo‐Abl study): Study design

“…The detailed procedure has been described elsewhere 18 . A three‐dimensional (3D) electroanatomic mapping will be performed with either the CARTO (Biosense Webster, Diamond Bat) or the NavX (Abbott) system.…”