Clinical trial NCT02698631: Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
Official title: Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Catheter Ablation
Radiofrequency
Fibrosis
Late-gadolinium enhanced MRI
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: University of Barcelona
First posted: 2016-03-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from atrial arrhythmias, lasting more than 30 sec.
timeFrame: 1 year
Secondary outcomes:
measure: Total time of radiofrequency application
timeFrame: During procedure
measure: Total X-ray time
timeFrame: During procedure
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospial Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Lluís Mont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bisbal F, Benito E, Teis A, Alarcon F, Sarrias A, Caixal G, Villuendas R, Garre P, Soto N, Cozzari J, Guasch E, Junca G, Prat-Gonzalez S, Perea RJ, Bazan V, Tolosana JM, Arbelo E, Bayes-Genis A, Mont L. Magnetic Resonance Imaging-Guided Fibrosis Ablation for the Treatment of Atrial Fibrillation: The ALICIA Trial. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008707. doi: 10.1161/CIRCEP.120.008707. Epub 2020 Oct 8.