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NCT Number: NCT02698631

Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Fibrosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional AF ablation

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total time of radiofrequency application

    Time frame: During procedure

  2. Total X-ray time

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

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

Registry information

Acronym: ALICIA

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 4, 2016
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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