Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging (ALICIA)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Conventional AF ablation
LGE-MRI guided AF ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter Ablation, Radiofrequency, Fibrosis, Late-gadolinium enhanced MRI
Eligibility 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.
Sites / Locations
- Hospital Universitari Germans Trias i Pujol
- Hospial Clinic of Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional AF ablation.
LGE-MRI guided AF ablation.
Arm Description
A standard radiofrequency AF ablation procedure will be carried out without LGE information.
Fibrosis information obtained from post-processed LGE-MRI will be used to guide AF ablation procedures.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total time of radiofrequency application
Total X-ray time
Full Information
NCT ID
NCT02698631
First Posted
February 4, 2016
Last Updated
February 10, 2021
Sponsor
Hospital Clinic of Barcelona
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT02698631
Brief Title
Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
Acronym
ALICIA
Official Title
Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter Ablation, Radiofrequency, Fibrosis, Late-gadolinium enhanced MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional AF ablation.
Arm Type
Active Comparator
Arm Description
A standard radiofrequency AF ablation procedure will be carried out without LGE information.
Arm Title
LGE-MRI guided AF ablation.
Arm Type
Experimental
Arm Description
Fibrosis information obtained from post-processed LGE-MRI will be used to guide AF ablation procedures.
Intervention Type
Procedure
Intervention Name(s)
Conventional AF ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
LGE-MRI guided AF ablation
Intervention Description
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 Measure Information:
Title
Freedom from atrial arrhythmias, lasting more than 30 sec.
Description
Recurrence is defined as any documented episode of AF/atrial tachycardia lasting more than 30 seconds, after a blanking period of 3 months.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Total time of radiofrequency application
Time Frame
During procedure
Title
Total X-ray time
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluís Mont, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospial Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33031713
Citation
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.
Results Reference
derived
Learn more about this trial
Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
We'll reach out to this number within 24 hrs