NCT02698631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2016

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

February 4, 2016

Last Update Submit

February 10, 2021

Conditions

Atrial Fibrillation

Keywords

Catheter AblationRadiofrequencyFibrosisLate-gadolinium enhanced MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Total time of radiofrequency application

    During procedure

  • Total X-ray time

    During procedure

Study Arms (2)

Conventional AF ablation.

ACTIVE COMPARATOR

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

Procedure: Conventional AF ablation

LGE-MRI guided AF ablation.

EXPERIMENTAL

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

Procedure: LGE-MRI guided AF ablation

Interventions

Conventional AF ablationPROCEDURE

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.

Conventional AF ablation.
LGE-MRI guided AF ablationPROCEDURE

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.

LGE-MRI guided AF ablation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospial Clinic of Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33031713DERIVED

MeSH Terms

Conditions

Atrial FibrillationFibrosis

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lluís Mont, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 4, 2016

First Posted

March 4, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)