Zero-fluoroscopic Cryoballoon Ablation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial

Conditions
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Atrial Fibrillation Paroxysmal

Intervention / Treatment
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* Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy
* Procedure: cryoablation (CBA) was performed under fluoroscopic guidance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: zero-fluoroscopic and conventional fluoroscopy groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conventional group<br>cryoablation (CBA) was performed under fluoroscopic guidance | Procedure: cryoablation (CBA) was performed under fluoroscopic guidance<br>* cryoablation (CBA) was performed under fluoroscopic guidance<br>|
| Experimental: Zero-X group<br>CBA was performed under intracardiac echocardiography guidance without fluoroscopy | Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy<br>* Zero-X group: Patients undergoing ICE-guided CBA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure time | comparison of radiation exposure time between the two groups | 1 day | 
| Radiation exposure dose | comparison of radiation exposure dose between the two groups | 1 day | 
| acute success rate | successful rate of pulmonary vein isolation | 1 day | 
| Recurrence rate of atrial tachyarrhythmias | long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Procedure time between two groups | 1 day |