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| Name | Class |
|---|---|
| Institut d'Investigacions Biomèdiques August Pi i Sunyer | OTHER |
| University of Barcelona | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional AF ablation. | Active Comparator | A standard radiofrequency AF ablation procedure will be carried out without LGE information. |
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| LGE-MRI guided AF ablation. | Experimental | Fibrosis information obtained from post-processed LGE-MRI will be used to guide AF ablation procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Total time of radiofrequency application | During procedure | |
| Total X-ray time | During procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lluís Mont, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospial Clinic of Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33031713 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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).
|
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| Barcelona |
| 08036 |
| Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |