Zero-fluoroscopic Cryoballoon Ablation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05711589

Enrollment

100

Registered

2023-02-03

Start date

2020-01-01

Completion date

2022-12-31

Last updated

2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Paroxysmal

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.

Interventions

PROCEDURECBA was performed under intracardiac echocardiography guidance without fluoroscopy

Zero-X group: Patients undergoing ICE-guided CBA

PROCEDUREcryoablation (CBA) was performed under fluoroscopic guidance

cryoablation (CBA) was performed under fluoroscopic guidance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

zero-fluoroscopic and conventional fluoroscopy groups

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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
acute success rate	1 day	successful rate of pulmonary vein isolation
Recurrence rate of atrial tachyarrhythmias	3 months	long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure

Secondary

Measure	Time frame	Description
Procedure time	1 day	Procedure time between two groups

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026