Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation Paroxysmal
- Sponsor
- Pusan National University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Radiation exposure time
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.
Detailed Description
Patients (n=100) undergoing de novo CBA for paroxysmal AF were randomly assigned (1:1) to zero-fluoroscopic (Zero-X) and conventional fluoroscopy groups. Radiation exposure, procedural time, acute and long term outcome were analyzed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation
Exclusion Criteria
- •age \< 18 years
- •history of AF ablation or cardiac surgery
- •contraindication to oral anticoagulants
- •presence of intracardiac thrombus or significant coronary artery disease on cardiac computed tomography prior to the procedure.
Outcomes
Primary Outcomes
Radiation exposure time
Time Frame: 1 day
comparison of radiation exposure time between the two groups
Radiation exposure dose
Time Frame: 1 day
comparison of radiation exposure dose between the two groups
Recurrence rate of atrial tachyarrhythmias
Time Frame: 3 months
long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
acute success rate
Time Frame: 1 day
successful rate of pulmonary vein isolation
Secondary Outcomes
- Procedure time(1 day)