Zero-fluoroscopic Cryoballoon Ablation

Pusan National University

Status: Completed

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy; Procedure: cryoablation (CBA) was performed under fluoroscopic guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT05711589

HALLYM 2019-04-025-001

Details and patient eligibility

About

This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

conventional group

Placebo Comparator group

Description:

cryoablation (CBA) was performed under fluoroscopic guidance

Treatment:

Procedure: cryoablation (CBA) was performed under fluoroscopic guidance

Zero-X group

Experimental group

Description:

CBA was performed under intracardiac echocardiography guidance without fluoroscopy

Treatment:

Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy