Open AccessA 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
Author(s) -
Miyamoto Koji,
Hasegawa Kanae,
Takahashi Hiroki,
Masue Yoh,
Kataoka Naoya,
Fukuzawa Koji,
Ashikaga Keiichi,
Noda Takashi,
Satomi Kazuhiro,
Tada Hiroshi,
Takagi Masahiko,
Yasuda Satoshi,
Kusano Kengo
Publication year - 2020
Publication title -
journal of arrhythmia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.463
H-Index - 21
eISSN - 1883-2148
pISSN - 1880-4276
DOI - 10.1002/joa3.12322
Subject(s) - medicine , atrial fibrillation , ablation , ejection fraction , cardiology , heart failure , catheter ablation , clinical endpoint , pulmonary vein , radiofrequency ablation , clinical trial , multicenter trial , randomized controlled trial , multicenter study
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.