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...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2020-06-01
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| Series: | Journal of Arrhythmia |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/joa3.12322 |
| _version_ | 1818324419546710016 |
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| author | Koji Miyamoto Kanae Hasegawa Hiroki Takahashi Yoh Masue Naoya Kataoka Koji Fukuzawa Keiichi Ashikaga Takashi Noda Kazuhiro Satomi Hiroshi Tada Masahiko Takagi Satoshi Yasuda Kengo Kusano |
| author_facet | Koji Miyamoto Kanae Hasegawa Hiroki Takahashi Yoh Masue Naoya Kataoka Koji Fukuzawa Keiichi Ashikaga Takashi Noda Kazuhiro Satomi Hiroshi Tada Masahiko Takagi Satoshi Yasuda Kengo Kusano |
| author_sort | Koji Miyamoto |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T11:28:17Z |
| format | Article |
| id | doaj.art-84be084e53464b9e9c38d3db67571a61 |
| institution | Directory Open Access Journal |
| issn | 1880-4276 1883-2148 |
| language | English |
| last_indexed | 2024-12-13T11:28:17Z |
| publishDate | 2020-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Arrhythmia |
| spelling | doaj.art-84be084e53464b9e9c38d3db67571a612022-12-21T23:48:03ZengWileyJournal of Arrhythmia1880-42761883-21482020-06-0136344945510.1002/joa3.12322A multicenter study comparing the outcome of catheter ablation of atrial fibrillation between cryoballoon and radiofrequency ablation in patients with heart failure (CRABL‐HF): Study designKoji Miyamoto0Kanae Hasegawa1Hiroki Takahashi2Yoh Masue3Naoya Kataoka4Koji Fukuzawa5Keiichi Ashikaga6Takashi Noda7Kazuhiro Satomi8Hiroshi Tada9Masahiko Takagi10Satoshi Yasuda11Kengo Kusano12Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita JapanDepartment of Cardiovascular Medicine University of Fukui Yoshida JapanDepartment of Medicine II Kansai Medical University Hirakata JapanSecond Department of Internal Medicine University of Toyama Toyama JapanSecond Department of Internal Medicine University of Toyama Toyama JapanSection of Arrhythmia Division of Cardiovascular Medicine Department of Internal Medicine Kobe University Graduate School of Medicine Kobe JapanDepartment of Cardiovascular Medicine Miyazaki Medical Association Hospital Miyazaki JapanDepartment of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita JapanDepartment of Cardiovascular Medicine Tokyo Medical University Hospital Tokyo JapanDepartment of Cardiovascular Medicine University of Fukui Yoshida JapanDepartment of Medicine II Kansai Medical University Hirakata JapanDepartment of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita JapanDepartment of Cardiovascular Medicine National Cerebral and Cardiovascular Center Suita JapanAbstract 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.https://doi.org/10.1002/joa3.12322AFcryoballoonRF ablation |
| spellingShingle | Koji Miyamoto Kanae Hasegawa Hiroki Takahashi Yoh Masue Naoya Kataoka Koji Fukuzawa Keiichi Ashikaga Takashi Noda Kazuhiro Satomi Hiroshi Tada Masahiko Takagi Satoshi Yasuda Kengo Kusano 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 Journal of Arrhythmia AF cryoballoon RF ablation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | AF cryoballoon RF ablation |
| url | https://doi.org/10.1002/joa3.12322 |
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