Zero-fluoroscopic Cryoballoon Ablation

February 2, 2023 updated by: Pusan National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: conventional group
cryoablation (CBA) was performed under fluoroscopic guidance
Procedure: cryoablation (CBA) was performed under fluoroscopic guidance
cryoablation (CBA) was performed under fluoroscopic guidance
EXPERIMENTAL: Zero-X group
CBA was performed under intracardiac echocardiography guidance without fluoroscopy
Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy
Zero-X group: Patients undergoing ICE-guided CBA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: 1 day
Procedure time between two groups
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Study Chair: Hong Euy Lim, MD, Hallym University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HALLYM 2019-04-025-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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