Rotational Angiography in Cryoballoon Ablation

University of Zagreb

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Rotational angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT04293757

RA001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• longstanding persistent atrial fibrillation
• renal failure
• contrast allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 2 patient groups

Rotational angio

Experimental group

Description:

Patients that will undergo 3D rotational angiography before cryoballoon ablation

Treatment:

Procedure: Rotational angiography

No rotational angio

No Intervention group

Description:

Patients that will receive no preprocedural imaging before cryoballoon ablation