This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted). Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGMarienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Rhineland-Palatinate, Germany
NOT_YET_RECRUITINGFeasibility of the Rodeo Micro Mapping Catheter
Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.
Time frame: 1-3 hours
Positioning of the Rodeo Micro Mapping Catheter
Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible
Time frame: 1-3 hours
Safety of the Rodeo Micro Mapping Catheter.
Percentage of adverse events related to the Rodeo Micro Mapping Catheter
Time frame: 1-3 day follow-up period
Efficacy of the Rodeo Micro Mapping Catheter
Percentage of successfully isolated pulmonary veins
Time frame: 1-3 hours
Real-time pulmonary vein isolation
Time from beginning of the freeze to conduction blockade (time to effect)
Time frame: 1-3 hours
Procedural safety
Procedure-related adverse events
Time frame: 1-3 hours
Total procedure time
Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath
Time frame: 1-3 hours
Cryoablation catheter procedure time
Cryoablation catheter procedure time defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application
Time frame: 1-3 hours
Total fluoroscopy time and dose
Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath
Time frame: 1-3 hours
Cryoablation catheter fluoroscopy time and dose
Cryoablation catheter fluoroscopy time and dose defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application
Time frame: 1-3 hours
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