- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02698631
Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging (ALICIA)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Barcelona, Spain, 08036
- Hospial Clinic of Barcelona
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Conventional AF ablation.
A standard radiofrequency AF ablation procedure will be carried out without LGE information.
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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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from atrial arrhythmias, lasting more than 30 sec.
Time Frame: 1 year
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Recurrence is defined as any documented episode of AF/atrial tachycardia lasting more than 30 seconds, after a blanking period of 3 months.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total time of radiofrequency application
Time Frame: During procedure
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During procedure
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Total X-ray time
Time Frame: During procedure
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During procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lluís Mont, MD, PhD, Hospital Clinic of Barcelona
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALICIA-FA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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