Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE)

Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007541. doi: 10.1161/CIRCEP.119.007541. Epub 2019 Dec 12.


Background: Balloon catheters facilitate pulmonary vein (PV) isolation, but current technology is limited by either a single ablative element, potentially leading to over-ablation of thin and under-ablation of thick tissue, or prolonged procedure times. Visualized by electroanatomical mapping, a novel compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes can simultaneously and independently deliver energy. Herein, we evaluated the feasibility, safety, and short-term efficacy of this radiofrequency balloon in a multicenter, single-arm, first-in-human study.

Methods: Paroxysmal atrial fibrillation patients underwent PV isolation with the radiofrequency balloon delivered over-the-wire with a deflectable 13.5F sheath. Radiofrequency energy is delivered simultaneously from all electrodes-up to 30 s posteriorly and 60 s anteriorly. Esophageal temperature was monitored in all patients; the esophagus was also mechanically deviated in 10 patients.

Results: At 4 sites, 39 patients were treated by 9 operators. The radiofrequency balloon isolated all targeted PVs (152/152), 79.6% with a single application. Electrical reconnection occurred in only 7/150 PVs (4.7%) on adenosine/isoproterenol challenge. Mean procedure, balloon dwell, and fluoroscopy times were 101.6, 40.5, and 17.4 min, respectively. Esophagogastroduodenoscopy revealed asymptomatic esophageal erythema in 5 patients. Phrenic nerve palsy occurred in a patient in whom phrenic pacing was inadvertently omitted. At 3 months, imaging revealed no PV stenosis, and early atrial arrhythmia recurrence occurred in only 10/39 (25.6%) patients.

Conclusions: The compliant radiofrequency balloon can directionally tailor energy delivery for efficient, effective, and reasonably safe acute PV isolation.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: ISRCTN 11764506.

Keywords: atrial fibrillation; catheter ablation; esophagus; multielectrodes; pulmonary veins.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Action Potentials
  • Aged
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / surgery*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheters*
  • Catheter Ablation / adverse effects
  • Catheter Ablation / instrumentation*
  • Equipment Design
  • Europe
  • Female
  • Heart Rate*
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / etiology
  • Prospective Studies
  • Pulmonary Veins / physiopathology
  • Pulmonary Veins / surgery*
  • Recurrence
  • Time Factors
  • Treatment Outcome
  • United States