Atrial Fibrillation
Conditions
Keywords
preprocedural imaging, Atrial Fibrillation, Rotational angiography
Brief 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.
Detailed 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.
Interventions
PROCEDURERotational angiography
Preprocedural imaging before ablation
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* paroxysmal atrial fibrillation * persistent atrial fibrillation * scheduled for cryoballoon ablation
Exclusion criteria
* longstanding persistent atrial fibrillation * renal failure * contrast allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ablation success rates | 1 year | comparison of freedom from atrial fibrillation after ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure duration | 1 year | comparison of time required to finish the ablation procedure |
| radiation exposure | 1 year | comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2. |
| contrast expenditure | 1 year | comparison of contrast expenditure (milliliters of contrast used) between 2 groups |
| complication rates | 1 year | comparison of complication rates between 2 groups |
Countries
Croatia
Outcome results
None listed