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 : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Conventional AF ablation Procedure: LGE-MRI guided AF ablation||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||September 2020|
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).
- 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.
- Total time of radiofrequency application [ Time Frame: During procedure ]
- Total X-ray time [ Time Frame: During procedure ]
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
|Hospital Universitari Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Hospial Clinic of Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Lluís Mont, MD, PhD||Hospital Clínic de Barcelona|