Atrial Fibrillation Clinical Trial
Official title:
Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation
NCT number | NCT04293757 |
Other study ID # | RA001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | October 1, 2023 |
Verified date | November 2023 |
Source | University of Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | October 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - paroxysmal atrial fibrillation - persistent atrial fibrillation - scheduled for cryoballoon ablation Exclusion Criteria: - longstanding persistent atrial fibrillation - renal failure - contrast allergy |
Country | Name | City | State |
---|---|---|---|
Croatia | KBC Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ablation success rates | comparison of freedom from atrial fibrillation after ablation procedure | 1 year | |
Secondary | procedure duration | comparison of time required to finish the ablation procedure | 1 year | |
Secondary | radiation exposure | comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2. | 1 year | |
Secondary | contrast expenditure | comparison of contrast expenditure (milliliters of contrast used) between 2 groups | 1 year | |
Secondary | complication rates | comparison of complication rates between 2 groups | 1 year |
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