ALICIA: Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT02698631

Collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer (Other), University of Barcelona (Other)

154

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Conventional AF ablation Procedure: LGE-MRI guided AF ablation	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional AF ablation. A standard radiofrequency AF ablation procedure will be carried out without LGE information.	Procedure: Conventional AF ablation Conventional AF ablation will be carried out according to the standard procedure. Atrial anatomical MRI information will be integrated into the navigation system. Ablation procedure will be carried out with a Smart Touch® catheter (temperature 45 °C, 40W or 30W for anterior or posterior wall, respectively). Both in first and re-do procedures, procedure endpoint will be electrical isolation of all pulmonary veins.
Experimental: LGE-MRI guided AF ablation. Fibrosis information obtained from post-processed LGE-MRI will be used to guide AF ablation procedures.	Procedure: LGE-MRI guided AF ablation Post-processed LGE-MRI will be used to identify left atrial fibrotic patches and lesions surrounding pulmonary veins (re-do procedures). Both MRI atrial anatomical and fibrosis information will be integrated into the navigation system. Ablation procedures will be carried out with a SmartTouch® catheter (temperature 45°C, 40W or 30W for anterior or posterior wall, respectively). Procedural end-point for first ablation procedures will be isolation of all pulmonary veins, and encirclement and isolation of all atrial fibrotic areas. In re-do procedures, all left atrial fibrosis patches will be encircled and isolated and, for electrically non-isolated pulmonary veins, all anatomical gaps in lesions surrounding pulmonary veins (as identified in LGE-MRI) will be closed.

Arm

Intervention/Treatment

Active Comparator: Conventional AF ablation.

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

Procedure: Conventional AF ablation

Conventional AF ablation will be carried out according to the standard procedure. Atrial anatomical MRI information will be integrated into the navigation system. Ablation procedure will be carried out with a Smart Touch® catheter (temperature 45 °C, 40W or 30W for anterior or posterior wall, respectively). Both in first and re-do procedures, procedure endpoint will be electrical isolation of all pulmonary veins.

Experimental: LGE-MRI guided AF ablation.

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

Procedure: LGE-MRI guided AF ablation

Post-processed LGE-MRI will be used to identify left atrial fibrotic patches and lesions surrounding pulmonary veins (re-do procedures). Both MRI atrial anatomical and fibrosis information will be integrated into the navigation system. Ablation procedures will be carried out with a SmartTouch® catheter (temperature 45°C, 40W or 30W for anterior or posterior wall, respectively). Procedural end-point for first ablation procedures will be isolation of all pulmonary veins, and encirclement and isolation of all atrial fibrotic areas. In re-do procedures, all left atrial fibrosis patches will be encircled and isolated and, for electrically non-isolated pulmonary veins, all anatomical gaps in lesions surrounding pulmonary veins (as identified in LGE-MRI) will be closed.

Outcome Measures

Primary Outcome Measures

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

Total time of radiofrequency application [During procedure]
Total X-ray time [During procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	Hospial Clinic of Barcelona	Barcelona		Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
University of Barcelona

Investigators

Principal Investigator: Lluís Mont, MD, PhD, Hospital Clinic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Josep Lluis Mont Girbau, MD PhD, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT02698631

Other Study ID Numbers:

ALICIA-FA

First Posted:

Mar 4, 2016

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Josep Lluis Mont Girbau, MD PhD, Hospital Clinic of Barcelona

Catheter Ablation

Radiofrequency

Fibrosis

Late-gadolinium enhanced MRI

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Feb 11, 2021