loading page

One-year outcomes of Pulmonary Vein Isolation with a novel cryoballoon: Primary results of the FROZEN AF Trial
  • +12
  • Ellenbogen KA,
  • Mittal S,
  • Niraj Varma,
  • Arash Aryana,
  • Nassir Marrouche,
  • Ante Anic,
  • Devi Nair,
  • Jean Champagne,
  • Saverio Iacopino,
  • Carlo de Asmundis,
  • Stanislav Weiner,
  • Makati K,
  • Jon Raybuck,
  • Elizabeth Richards,
  • Wilber Su
Ellenbogen KA
VA Richmond Medical Center

Corresponding Author:[email protected]

Author Profile
Mittal S
Valley Hospital
Author Profile
Niraj Varma
Cleveland Clinic
Author Profile
Arash Aryana
Mercy General Hospital
Author Profile
Nassir Marrouche
Tulane University School of Medicine
Author Profile
Ante Anic
Klinicki Bolnicki Centar Split Krizine
Author Profile
Devi Nair
Saint Bernards Medical Center
Author Profile
Jean Champagne
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Universite Laval
Author Profile
Saverio Iacopino
Maria Cecilia Hospital SpA
Author Profile
Carlo de Asmundis
Universitair Ziekenhuis Brussel Orthopedie
Author Profile
Stanislav Weiner
Christus Trinity Mother Frances Hospital Winnsboro
Author Profile
Makati K
St Joseph's Hospitals Foundation
Author Profile
Jon Raybuck
Boston Scientific Corp Arden Hills
Author Profile
Elizabeth Richards
Boston Scientific Corp Arden Hills
Author Profile
Wilber Su
Banner - University Medical Center Phoenix
Author Profile


Introduction: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multi-center, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. Methods and Results: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of 1 or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean±SD or Median (IQR). PVI was performed with a 28mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [transient 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), Antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved prior to discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. Conclusions: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomy present in patients with PAF. This cryoballoon system was safe and effective for treatment of patients with drug refractory or drug intolerant PAF.
Submitted to Journal of Cardiovascular Electrophysiology
29 Jan 20241st Revision Received
29 Jan 2024Assigned to Editor
29 Jan 2024Submission Checks Completed
29 Jan 2024Review(s) Completed, Editorial Evaluation Pending
29 Jan 2024Reviewer(s) Assigned
06 Feb 2024Editorial Decision: Accept