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This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional group | Placebo Comparator | cryoablation (CBA) was performed under fluoroscopic guidance |
|
| Zero-X group | Experimental | CBA was performed under intracardiac echocardiography guidance without fluoroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBA was performed under intracardiac echocardiography guidance without fluoroscopy | Procedure | Zero-X group: Patients undergoing ICE-guided CBA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation exposure time | comparison of radiation exposure time between the two groups | 1 day |
| Radiation exposure dose | comparison of radiation exposure dose between the two groups | 1 day |
| acute success rate | successful rate of pulmonary vein isolation | 1 day |
| Recurrence rate of atrial tachyarrhythmias | long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | Procedure time between two groups | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Euy Lim, MD | Hallym University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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zero-fluoroscopic and conventional fluoroscopy groups
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| cryoablation (CBA) was performed under fluoroscopic guidance | Procedure | cryoablation (CBA) was performed under fluoroscopic guidance |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |