Atrial Fibrillation ParoxysmalNCT05711589
Zero-fluoroscopic Cryoballoon Ablation
A study testing CBA was performed under intracardiac echocardiography guidance without fluoroscopy and cryoablation (CBA) was performed under fluoroscopic guidance in people with Atrial Fibrillation Paroxysmal, run by Pusan National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- CBA was performed under intracardiac echocardiography guidance without fluoroscopy and cryoablation (CBA) was performed under fluoroscopic guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- CBA was performed under intracardiac echocardiography guidance without fluoroscopy, cryoablation (CBA) was performed under fluoroscopic guidance
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBA was performed under intracardiac echocardiography guidance without fluoroscopyProcedure or surgery
Zero-X group: Patients undergoing ICE-guided CBA
cryoablation (CBA) was performed under fluoroscopic guidanceProcedure or surgery
cryoablation (CBA) was performed under fluoroscopic guidance
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Placebo comparator | cryoablation (CBA) was performed under fluoroscopic guidance Receives: Procedure: cryoablation (CBA) was performed under fluoroscopic guidance |
| Zero-X group | Experimental | CBA was performed under intracardiac echocardiography guidance without fluoroscopy Receives: Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure time
comparison of radiation exposure time between the two groups
Measured: 1 day
Radiation exposure dose
comparison of radiation exposure dose between the two groups
Measured: 1 day
acute success rate
successful rate of pulmonary vein isolation
Measured: 1 day
Recurrence rate of atrial tachyarrhythmias
long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
Measured: 3 months
Secondary outcomes (1)
Procedure time
Procedure time between two groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jan 2020
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- zero-fluoroscopic and conventional fluoroscopy groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Euy Lim, MD, Study chair, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711589
- Sponsor's protocol ID
- HALLYM 2019-04-025-001
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05711589
- Acronym / sponsor ID
- HALLYM 2019-04-025-001
- Conditions
- Atrial Fibrillation Paroxysmal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- zero-fluoroscopic and conventional fluoroscopy groups
| Arm | Type | Receives |
|---|---|---|
| conventional group | Placebo comparator | Procedure: cryoablation (CBA) was performed under fluoroscopic guidancecryoablation (CBA) was performed under fluoroscopic guidance |
| Zero-X group | Experimental | Procedure: CBA was performed under intracardiac echocardiography guidance without fluoroscopyCBA was performed under intracardiac echocardiography guidance without fluoroscopy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBA was performed under intracardiac echocardiography guidance without fluoroscopyZero-X group: Patients undergoing ICE-guided CBA | Procedure or surgery | Zero-X group |
| cryoablation (CBA) was performed under fluoroscopic guidancecryoablation (CBA) was performed under fluoroscopic guidance | Procedure or surgery | conventional group |
Primary outcome
Radiation exposure time
Time frame: 1 day
comparison of radiation exposure time between the two groups
Radiation exposure dose
Time frame: 1 day
comparison of radiation exposure dose between the two groups
acute success rate
Time frame: 1 day
successful rate of pulmonary vein isolation
Recurrence rate of atrial tachyarrhythmias
Time frame: 3 months
long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
1 secondary outcome
Procedure time
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Euy Lim, MD study chair
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBA was performed under intracardiac echocardiography guidance without fluoroscopy and cryoablation (CBA) was performed under fluoroscopic guidance in people with Atrial Fibrillation Paroxysmal, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure time (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.