Rotational Angiography in Cryoballoon Ablation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Rotational angiography

• Registration Number: NCT04293757
• Lead Sponsor: University of Zagreb

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-03-01
• Study First Posted: 2020-03-03
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• paroxysmal atrial fibrillation
• persistent atrial fibrillation
• scheduled for cryoballoon ablation

Exclusion Criteria

• longstanding persistent atrial fibrillation
• renal failure
• contrast allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotational angio	Rotational angiography	Patients that will undergo 3D rotational angiography before cryoballoon ablation

Primary Outcome Measures

Name	Time	Method
ablation success rates	1 year	comparison of freedom from atrial fibrillation after ablation procedure

Secondary Outcome Measures

Name	Time	Method
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
procedure duration	1 year	comparison of time required to finish the ablation procedure
complication rates	1 year	comparison of complication rates between 2 groups

Trial Locations

Locations (1)

KBC Zagreb; 🇭🇷 Zagreb, Croatia