Rotational Angiography in Cryoballoon Ablation

NCT ID: NCT04293757

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-10-01

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotational angio

Patients that will undergo 3D rotational angiography before cryoballoon ablation

Group Type: EXPERIMENTAL

Rotational angiography

Intervention Type: PROCEDURE

Preprocedural imaging before ablation

No rotational angio

Patients that will receive no preprocedural imaging before cryoballoon ablation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rotational angiography

Preprocedural imaging before ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• longstanding persistent atrial fibrillation
• renal failure
• contrast allergy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Vedran Velagic

Assistant professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vedran Velagić, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Centre Zagreb

Locations

KBC Zagreb

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

RA001

Identifier Type: -

Identifier Source: org_study_id