Back to resultsZero-fluoroscopic Cryoballoon Ablation
Primary Purpose
Atrial Fibrillation Paroxysmal
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CBA was performed under intracardiac echocardiography guidance without fluoroscopy
cryoablation (CBA) was performed under fluoroscopic guidance
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation Paroxysmal
Eligibility Criteria
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.
Sites / Locations
- Hallym University Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
conventional group
Zero-X group
Arm Description
cryoablation (CBA) was performed under fluoroscopic guidance
CBA was performed under intracardiac echocardiography guidance without fluoroscopy
Outcomes
Primary Outcome Measures
Radiation exposure time
comparison of radiation exposure time between the two groups
Radiation exposure dose
comparison of radiation exposure dose between the two groups
acute success rate
successful rate of pulmonary vein isolation
Recurrence rate of atrial tachyarrhythmias
long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
Secondary Outcome Measures
Procedure time
Procedure time between two groups
Full Information
NCT ID
NCT05711589
First Posted
January 18, 2023
Last Updated
February 2, 2023
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05711589
Brief Title
Zero-fluoroscopic Cryoballoon Ablation
Official Title
Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Paroxysmal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
zero-fluoroscopic and conventional fluoroscopy groups
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional group
Arm Type
Placebo Comparator
Arm Description
cryoablation (CBA) was performed under fluoroscopic guidance
Arm Title
Zero-X group
Arm Type
Experimental
Arm Description
CBA was performed under intracardiac echocardiography guidance without fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
CBA was performed under intracardiac echocardiography guidance without fluoroscopy
Intervention Description
Zero-X group: Patients undergoing ICE-guided CBA
Intervention Type
Procedure
Intervention Name(s)
cryoablation (CBA) was performed under fluoroscopic guidance
Intervention Description
cryoablation (CBA) was performed under fluoroscopic guidance
Primary Outcome Measure Information:
Title
Radiation exposure time
Description
comparison of radiation exposure time between the two groups
Time Frame
1 day
Title
Radiation exposure dose
Description
comparison of radiation exposure dose between the two groups
Time Frame
1 day
Title
acute success rate
Description
successful rate of pulmonary vein isolation
Time Frame
1 day
Title
Recurrence rate of atrial tachyarrhythmias
Description
long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Procedure time
Description
Procedure time between two groups
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Euy Lim, MD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Zero-fluoroscopic Cryoballoon Ablation
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