Zero-fluoroscopic Cryoballoon Ablation
- Conditions
- Atrial Fibrillation Paroxysmal
- Registration Number
- NCT05711589
- Lead Sponsor
- Pusan National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Radiation exposure time 1 day comparison of radiation exposure time between the two groups
Radiation exposure dose 1 day comparison of radiation exposure dose between the two groups
Recurrence rate of atrial tachyarrhythmias 3 months long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
acute success rate 1 day successful rate of pulmonary vein isolation
- Secondary Outcome Measures
Name Time Method Procedure time 1 day Procedure time between two groups
Trial Locations
- Locations (1)
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Hallym University Sacred Heart Hospital🇰🇷Anyang, Korea, Republic of