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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698631
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : October 25, 2019
Sponsor:
Collaborators:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
University of Barcelona
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Conventional AF ablation Procedure: LGE-MRI guided AF ablation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
Study Start Date : January 2016
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Total time of radiofrequency application [ Time Frame: During procedure ]
  2. Total X-ray time [ Time Frame: During procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698631


Locations
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Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospial Clinic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
University of Barcelona
Investigators
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Principal Investigator: Lluís Mont, MD, PhD Hospital Clínic de Barcelona
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Responsible Party: Josep Lluis Mont Girbau, MD PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02698631    
Other Study ID Numbers: ALICIA-FA
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Josep Lluis Mont Girbau, Hospital Clinic of Barcelona:
Catheter Ablation
Radiofrequency
Fibrosis
Late-gadolinium enhanced MRI
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes