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Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

NCT02698631 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2021-02-11

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • University of Barcelona

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Lluís Mont, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-06-30
Completion
2020-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698631 on ClinicalTrials.gov