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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04293757
Study type Interventional
Source University of Zagreb
Contact
Status Completed
Phase N/A
Start date September 1, 2019
Completion date October 1, 2023

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