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Related Experiment Video

Updated: Mar 10, 2026

Reduction of Iatrogenic Atrial Septal Defects with an Anterior and Inferior Transseptal Puncture Site when Operating the Cryoballoon Ablation Catheter
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CoolLoop® First: A First In Man Study To Test A Novel Circular Cryoablation System In Paroxysmal Atrial Fibrillation.

Markus Stuehlinger1, Simon Hoenig2, Karin Spuller1

  • 1University Clinic of Internal Medicine III / Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria.

Journal of Atrial Fibrillation
|December 14, 2016
PubMed
Summary

Pulmonary vein isolation using the novel CoolLoop® cryoablation catheter is feasible and safe for treating paroxysmal atrial fibrillation. Further studies will compare its long-term effectiveness against established ablation methods.

Keywords:
AblationAntrumCryothermiaLeft Atrial AblationPulmonary Vein Isolation

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Area of Science:

  • Cardiology
  • Electrophysiology
  • Medical Devices

Background:

  • Pulmonary vein (PV) isolation is a primary treatment for paroxysmal atrial fibrillation (AF).
  • The CoolLoop® cryoablation catheter was designed for effective PV lesion creation.
  • This study assesses the initial human feasibility and safety of the CoolLoop® system.

Purpose of the Study:

  • To evaluate the feasibility and safety of the CoolLoop® cryoablation catheter for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
  • To assess the initial performance of this novel ablation technology in a human clinical setting.

Main Methods:

  • 10 patients with paroxysmal AF underwent pulmonary vein isolation using the CoolLoop® catheter.
  • The catheter was positioned at each PV antrum, followed by double-freezes.
  • Phrenic nerve function was monitored during right-sided ablations.

Main Results:

  • Successful positioning of the CoolLoop® catheter in all PVs.
  • A mean of 5.2-6.3 cryoablations were performed per vein.
  • PV isolation was achieved in 50-60% of veins using this system alone.
  • Minor complications included groin hematoma and transient ST-elevation.

Conclusions:

  • Pulmonary vein isolation for paroxysmal AF with the CoolLoop® catheter is feasible and appears safe.
  • Long-term clinical efficacy requires further evaluation and comparison with existing ablation catheters.