AIMS: To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI). METHODS AND RESULTS: This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7 days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12 months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of ≥1 PVs after adenosine/isoproterenol challenge was observed in 9.3% (30/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12 months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12 months. CONCLUSION: PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT03437733.
- Keywords
- Atrial fibrillation, Electrophysiological mapping, Pulmonary vein isolation, Quality of life, Radiofrequency ablation, Radiofrequency balloon catheter,
- MeSH
- Electrodes MeSH
- Atrial Fibrillation * diagnosis surgery MeSH
- Catheter Ablation * adverse effects MeSH
- Catheters MeSH
- Quality of Life MeSH
- Humans MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Pulmonary Veins * diagnostic imaging surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Keywords
- Ablation, Anticoagulation, Arrhythmia, Atrial fibrillation, Atrial flutter, Atrial tachycardia, Catheter ablation, Stroke, Surgical ablation,
- MeSH
- Atrial Fibrillation diagnosis physiopathology surgery MeSH
- Catheter Ablation adverse effects standards MeSH
- Consensus MeSH
- Cryosurgery adverse effects standards MeSH
- Humans MeSH
- Risk Factors MeSH
- Cardiac Catheterization adverse effects standards MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Practice Guideline MeSH
- Keywords
- Ablation, Anticoagulation, Arrhythmia, Atrial fibrillation, Atrial flutter, Atrial tachycardia, Catheter ablation, Stroke, Surgical ablation,
- MeSH
- Atrial Fibrillation diagnosis physiopathology surgery MeSH
- Catheter Ablation adverse effects standards MeSH
- Consensus MeSH
- Cryosurgery adverse effects standards MeSH
- Humans MeSH
- Risk Factors MeSH
- Cardiac Catheterization adverse effects standards MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Practice Guideline MeSH
- Keywords
- Ablation, Anticoagulation, Arrhythmia, Atrial fibrillation, Atrial flutter, Atrial tachycardia, Catheter ablation, Stroke, Surgical ablation,
- MeSH
- Ablation Techniques standards MeSH
- Atrial Fibrillation surgery MeSH
- Cardiology * MeSH
- Catheter Ablation standards MeSH
- Consensus Development Conferences as Topic * MeSH
- Humans MeSH
- Heart Conduction System surgery MeSH
- Societies, Medical * MeSH
- Check Tag
- Humans MeSH
- Publication type
- News MeSH
- Keywords
- Ablation, Anticoagulation, Arrhythmia, Atrial fibrillation, Atrial flutter, Atrial tachycardia, Catheter ablation, Stroke, Surgical ablation,
- MeSH
- Atrial Fibrillation diagnosis physiopathology surgery MeSH
- Cardiac Surgical Procedures standards MeSH
- Catheter Ablation standards MeSH
- Consensus MeSH
- Humans MeSH
- Risk Factors MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Keywords
- AAD, antiarrhythmic drug, AF, atrial fibrillation, AFL, atrial flutter, Ablation, Anticoagulation, Arrhythmia, Atrial fibrillation, Atrial flutter, Atrial tachycardia, CB, cryoballoon, CFAE, complex fractionated atrial electrogram, Catheter ablation, LA, left atrial, LAA, left atrial appendage, LGE, late gadolinium-enhanced, LOE, level of evidence, MRI, magnetic resonance imaging, OAC, oral anticoagulation, RF, radiofrequency, Stroke, Surgical ablation,
- Publication type
- Journal Article MeSH
