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NCT05711589 Clinical Trial

Zero-fluoroscopic Cryoballoon Ablation

Atrial Fibrillation Paroxysmal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05711589
Other study ID # HALLYM 2019-04-025-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information
Verified date February 2023
Source Pusan National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• CBA was performed under intracardiac echocardiography guidance without fluoroscopy
Zero-X group: Patients undergoing ICE-guided CBA
• cryoablation (CBA) was performed under fluoroscopic guidance
cryoablation (CBA) was performed under fluoroscopic guidance

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang

Sponsors (1)
Lead Sponsor Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiation exposure time comparison of radiation exposure time between the two groups 1 day
Primary Radiation exposure dose comparison of radiation exposure dose between the two groups 1 day
Primary acute success rate successful rate of pulmonary vein isolation 1 day
Primary Recurrence rate of atrial tachyarrhythmias long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure 3 months
Secondary Procedure time Procedure time between two groups 1 day
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