Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging (ALICIA)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: LGE-MRI guided AF ablation; Procedure: Conventional AF ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02698631

ALICIA-FA

Details and patient eligibility

About

The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified by late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial fibrillation (AF) ablation outcomes.

Full description

Atrial fibrosis is a hallmark of the AF substrate. An accurate identification and localization of myocardial fibrosis areas prior to an ablation procedure by means of LGE-MRI might help to target atrial areas harboring AF, thereby improving ablation outcomes and reducing AF recurrences.

In order to test this hypothesis, we will conduct a randomized study comparing the isolation of pulmonary veins without fibrosis imaging (conventional ablation procedure) vs. isolation of the pulmonary veins and pathological (fibrotic) tissue with the aid of LGE-MRI. Fibrotic tissue patches will be encircled and isolated in all patients in the active arm; furthermore, LGE-MRI will be used to identify, locate and guide ablation catheter to anatomical gaps surrounding pulmonary veins in re-do procedures.

Eventually, we will identify an optimized ablation strategy in patients undergoing AF radiofrequency ablation on the basis of left atrium (LA) fibrosis characterization.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing a first or subsequent ablation procedure.
• Pre-procedural 3 Tesla LGE-MRI.
• Referred for radiofrequency ablation of pulmonary veins (paroxysmal, persistent or long-standing AF).
• Signed informed consent.

Exclusion criteria

• Claustrophobia.
• Refusal to participate in the study.
• Presence of atrial thrombus.
• LA anteroposterior diameter >55 mm.
• Major renal impairment.
• Contrast allergy.
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Conventional AF ablation.

Active Comparator group

Description:

A standard radiofrequency AF ablation procedure will be carried out without LGE information.

Treatment:

Procedure: Conventional AF ablation

LGE-MRI guided AF ablation.

Experimental group

Description:

Fibrosis information obtained from post-processed LGE-MRI will be used to guide AF ablation procedures.

Treatment:

Procedure: LGE-MRI guided AF ablation