Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Conventional AF ablation; Procedure: LGE-MRI guided AF ablation

• Registration Number: NCT02698631
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-27
• Study First Posted: 2016-03-04
• Primary Completion: 2019-06
• Study Completion: 2020-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional AF ablation.	Conventional AF ablation	A standard radiofrequency AF ablation procedure will be carried out without LGE information.
LGE-MRI guided AF ablation.	LGE-MRI guided AF ablation	Fibrosis information obtained from post-processed LGE-MRI will be used to guide AF ablation procedures.

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmias, lasting more than 30 sec.	1 year	Recurrence is defined as any documented episode of AF/atrial tachycardia lasting more than 30 seconds, after a blanking period of 3 months.

Secondary Outcome Measures

Name	Time	Method
Total X-ray time	During procedure
Total time of radiofrequency application	During procedure

Trial Locations

Locations (2)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospial Clinic of Barcelona; 🇪🇸 Barcelona, Spain