Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Primary Endpoint Safety and tolerability of ablation using the AFreeze Cryoablation System
      consisting of the ablation CoolLoop® catheter, its steerable sheath and the cryoconsole
      Cryo-Caddy will be assessed and expressed in number of participants with Adverse Events
      (AEs).
    

Detailed description: 
      Therefore, the primary endpoint will be a measurement of the following parameters and
      expressed in number of participants with AE:

        -  deformation of the catheter loop resulting in entrapment of the catheter in the heart
           and difficulties removing the catheter during visit 3 (treatment)

        -  phrenic nerve palsy during visit 3 (treatment)- onset and time course between visit 3
           (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage
           requiring surgery and hemorrhage requiring transfusion.

        -  onset and time course between visit 3 (treatment) and visit 9 (final visit) of
           atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic
           attack, and pulmonary vein (PV) stenosis requiring intervention.

      Secondary Endpoint

      The following parameters will be assessed and expressed in number of participants with
      AE/duration time:

        -  feasibility, defined by the ability to position the catheter in the proximal part in
           each of the PVs using an over-the-wire technique, forming the cryo-applicator of the
           catheter to a loop by operating the catheter handle, position-ing the loop at the wall
           of the PV antrum and delivering cryothermia.

        -  acute efficacy of catheter ablation is defined as the percentage of electrodes within
           the PV without measureable signals.

        -  clinical efficacy of catheter ablation defined by freedom of Atrial Fibrillation (AF)
           four, eight and twelve weeks after ablation.

        -  procedure time defined from introduction of the CoolLoop® catheter into the left atrium
           until removal of the CoolLoop® catheter from the left atrium after termination of the
           last cryoapplication.

        -  fluoroscopy time defined from introduction of the CoolLoop® catheter into the left
           atrium until removal of the CoolLoop® catheter from the left atrium after termination of
           the last cryoapplication.

        -  cumulative cryoablation time.

        -  onset and time course between visit 3 (treatment) and visit 5 (discharge) of
           pneumothorax, hemothorax, femoral pseudoaneurysm, arteriovenous fistulae, hemorrhage not
           requiring transfusion.
    

Intervention name(s): Cryoablation
Intervention type(s): Device
Intervention description(s): Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
Other intervention name(s): Cool Loop first; Cryoablation of Atrial Fibrillation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Cryoablation