Skip to main content
OpenTrials
Completed

NCT Number: NCT05711589

Zero-fluoroscopic Cryoballoon Ablation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Paroxysmal Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Sacred Heart Hospital

Anyang, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBA was performed under intracardiac echocardiography guidance without fluoroscopy

Procedure

Zero-X group: Patients undergoing ICE-guided CBA

cryoablation (CBA) was performed under fluoroscopic guidance

Procedure

cryoablation (CBA) was performed under fluoroscopic guidance

Primary outcomes

  1. Radiation exposure time

    Time frame: 1 day

    comparison of radiation exposure time between the two groups

  2. Radiation exposure dose

    Time frame: 1 day

    comparison of radiation exposure dose between the two groups

  3. acute success rate

    Time frame: 1 day

    successful rate of pulmonary vein isolation

  4. Recurrence rate of atrial tachyarrhythmias

    Time frame: 3 months

    long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure

Secondary outcomes

  1. Procedure time

    Time frame: 1 day

    Procedure time between two groups

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.