Status:
UNKNOWN
HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation
Lead Sponsor:
Universitätsklinikum Köln
Conditions:
Atrial Fibrillation and Flutter
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Pr...
Detailed Description
In several trials and real-life data pulmonary vein isolation (PVI) using the cryoballoon technique has been proven equal to RF-PVI for the treatment of paroxysmal atrial fibrillation (PAF). Due to th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04855890
Start Date
May 1 2021
End Date
August 1 2023
Last Update
July 26 2021
Active Locations (1)
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1
Department of electrophysiology, Heart Center Cologne, University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50937