Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

Atrial Fibrillation Clinical Trial

— ALICIA  

Official title:

Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698631
• Other study ID #: ALICIA-FA
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: September 2020

Study information

• Verified date: February 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospial Clinic of Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial arrhythmias, lasting more than 30 sec.	Recurrence is defined as any documented episode of AF/atrial tachycardia lasting more than 30 seconds, after a blanking period of 3 months.	1 year
Secondary	Total time of radiofrequency application		During procedure
Secondary	Total X-ray time		During procedure