HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (HIPAF)
Atrial Fibrillation and Flutter, Atrial Fibrillation, Paroxysmal Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation and Flutter focused on measuring atrial fibrillation, high power short duration, pulmonary vein isolation, cryo-ablation
Eligibility Criteria
Inclusion Criteria:
- Symptomatic non-valvular atrial fibrillation with no prior ablation with an indication for re-ablation according to current guidelines.
- Age 18-85 years.
- Patient is able to provide informed consent and is willing to comply with the study protocol.
Exclusion Criteria:
- Contraindications for left atrial ablation
- History of interventional or surgical AF-ablation
- History of stroke during the past 12 months
- BMI >40kg/m2
- History of mitral valve surgery
- Severe mitral valve regurgitation
- Inability to be treated with oral anticoagulation
- Presence of intracardiac thrombi
- Contraindication or absolute indication for one of the two strategies
- Pregnancy
- Participation in other clinical studies
- Unwilling to follow the study protocol and to attend follow-up visits
Sites / Locations
- Department of electrophysiology, Heart Center Cologne, University of CologneRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Cryo-Ablation
High Power Short Duration-Ablation
Cryo-Balloon (Arctic Front Advance ProTM, Medtronic, Minneapolis, MN, USA) will be advanced to the LA and navigated to the PV's using an inner-lumen circular mapping catheter (Achieve AdvanceTM, Medtronic, Minneapolis, MN, USA). After confirming complete PV sealing by the CB using occlusion angiograms cryothermal energy will be applied for min 120 seconds aiming at PV isolation of all PV's according to the clinical standard.
A detailed electroanatomical map of the left atrium during sinus rhythm will be acquired using Ensite (Abbott, St. Paul, MN, USA). Upon completion of the LA map, a second transseptal puncture will be performed in order to insert an ablation catheter. To achieve antral PVI irrigated radiofrequency current ablation will be performed using a power of 70W and a flush rate of 8-30ml/min with a duration of 5 seconds for the anterior and 7 seconds for the posterior LA. Ablation catheters used will contain Flexibilty (Abbott, St. Paul, MN, USA) and TactiFlex (Abbott, St. Paul, MN, USA).