NCT01687036

Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: afreeze GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cryoablation	Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2012-09-18
• Last updated: 2018-12-06
• Results posted: 2014-01-13

Locations

2 sites across 1 country: Austria