Rotational Angiography in Cryoballoon Ablation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Rotational angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paroxysmal atrial fibrillation persistent atrial fibrillation scheduled for cryoballoon ablation Exclusion Criteria: longstanding persistent atrial fibrillation renal failure contrast allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotational angio<br>Patients that will undergo 3D rotational angiography before cryoballoon ablation | Procedure: Rotational angiography<br>* Preprocedural imaging before ablation<br>|
| No Intervention: No rotational angio<br>Patients that will receive no preprocedural imaging before cryoballoon ablation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ablation success rates | comparison of freedom from atrial fibrillation after ablation procedure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preprocedural imaging, Atrial Fibrillation, Rotational angiography