Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective single-center randomized trial comparing the efficacy and safety of PV
      cryoablation with the Arctic Front® catheter versus the standard PV isolation using
      radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated
      from a clinical point of view and from the detection and quantification of AF episodes by
      means of the Reveal XT® implantable loop recorder.
    

Detailed description: 
      Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread
      technique for atrial fibrillation (AF) ablation. These procedures are difficult and
      time-consuming, because they require precise catheter manipulation and multiple
      radiofrequency applications. Thus, alternative techniques are being investigated to simplify
      the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation
      (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it
      can create a circumferential lesion around the PV ostium by delivering a single cryoenergy
      application.

      An implantable loop recorder for AF detection has been made available (Reveal XT®,
      Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic
      therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of
      different therapeutic strategies.

      This is a prospective single-center randomized trial comparing the efficacy and safety of PV
      cryoablation with the Arctic Front® catheter vs. the standard PV isolation using
      radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated
      from a clinical point of view and from the detection and quantification of AF episodes by
      means of the Reveal XT® implantable loop recorder.
    

Intervention name(s): Pulmonary vein cryoablation; Pulmonary vein radiofrequency ablation
Intervention type(s): Device; Device
Intervention description(s): A deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged.; Ablation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter > 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block.
Other intervention name(s): Cryoenergy balloon catheter ablation; Pulmonary vein isolation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Catheter ablation; Cryoenergy; Implantable loop recorder; Pulmonary vein