Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging (ALICIA)

February 10, 2021 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08036
        • Hospial Clinic of Barcelona
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional AF ablation.
A standard radiofrequency AF ablation procedure will be carried out without LGE information.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from atrial arrhythmias, lasting more than 30 sec.
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Total time of radiofrequency application
Time Frame: During procedure
During procedure
Total X-ray time
Time Frame: During procedure
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 27, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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