Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter

Condition(s) studied

Investigational drug(s) / intervention(s)

Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter: Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter

Study summary

All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting.

Eligibility

Primary outcome measure(s)

• Atrial arrhythmia recurrence after ablation — After 3 months post-ablation.
  The primary outcome endpoint is defined as arrhythmia-free survival during the follow-up. Arrhythmia recurrence is defined as any atrial tachyarrhythmias ≥30 s after a 90-day post-ablation blanking period.
• Procedural safety — Up to 7 days post-procedure (except for atrioesophageal fistula or pulmonary vein stenosis)
  The primary safety endpoint included any major periprocedural complications \[e.g. death, atrioesophageal fistula, stroke/transient ischaemic attack (TIA), pericardial effusion/tamponade with/without surgical treatment, myocardial infarction, and persistent phrenic palsy\] occurring within 7 days post-procedure (except for atrioesophageal fistula). Minor complications, including vascular access complications requiring treatment, pericarditis, and transient phrenic palsy will also be assessed.

Trial sites (1)

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