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There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.
Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure. Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional rotational angiography is least commonly used. However it has the advantage that it can be performed in the EP room just before the ablation procedure. There is still no consensus if any kind of imaging is really needed to perform safe and effective PVI.
The investigators want to determine if 3D rotational angiography (as a mode of preprocedural imaging) has positive impact on procedure safety and efficacy. Also the investigators want to compare the immediate procedure characteristics. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational angio | Experimental | Patients that will undergo 3D rotational angiography before cryoballoon ablation |
|
| No rotational angio | No Intervention | Patients that will receive no preprocedural imaging before cryoballoon ablation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational angiography | Procedure | Preprocedural imaging before ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| ablation success rates | comparison of freedom from atrial fibrillation after ablation procedure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| procedure duration | comparison of time required to finish the ablation procedure | 1 year |
| radiation exposure | comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vedran Velagić, MD, PhD | Clinical Hospital Centre Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Zagreb | Zagreb | 10000 | Croatia |
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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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| 1 year |
| contrast expenditure | comparison of contrast expenditure (milliliters of contrast used) between 2 groups | 1 year |
| complication rates | comparison of complication rates between 2 groups | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |