Zero-fluoroscopic Cryoballoon Ablation

Not Applicable

Completed

• Conditions: Atrial Fibrillation Paroxysmal
• Interventions: Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy; Procedure: cryoablation (CBA) was performed under fluoroscopic guidance

• 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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31
• Study First Submitted: 2023-01-18
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zero-X group	CBA was performed under intracardiac echocardiography guidance without fluoroscopy	CBA was performed under intracardiac echocardiography guidance without fluoroscopy
conventional group	cryoablation (CBA) was performed under fluoroscopic guidance	cryoablation (CBA) was performed under fluoroscopic guidance

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