Atrial Fibrillation Ablation
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|ClinicalTrials.gov Identifier: NCT03410966|
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 26, 2018
Objective. Atrial fibrillation (AF) recurrence after catheter ablation (CA) is a relevant clinical problem.
Methods. 123 patients with paroxysmal AF will be identified and screened for participation in this randomized, prospective, double blind, controlled placebo multicenter trial. 109 patients will be randomly assigned and enrolled in the study trial. Enrolled patients will receive magnetic atrial resonance and then will be treated by CA to receive pulmonary vein isolation (PVI). In this patients cytokines, inflammatory markers, and biomarkers such as ST2 protein and B type natriuretic peptide (BNP) will be evaluated at baseline, after CA, and during follow up. These biomarkers will be correlated to clinical outcomes (AF recurrences and heart failure progression and hospitalizations), and to fibrotic atrium extension as evaluated by magnetic resonance.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Heart Failure, Diastolic||Procedure: trans cateheter ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Paroxysmal Atrial Fibrillation Recurrences After Catheter Ablation: an Existing Correlation Between Oxidative Stress, Inflammation, Failing Heart Biomarkers and Atrial Fibrotic Remodeling.|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||November 1, 2017|
Experimental: Intervention group
All patients affected by paroxysmal symptomatic atrial fibrillation, and anti-arrhythmic drug refractory atrial fibrillation will receive a trans catheter ablation therapy (intervention).
Procedure: trans cateheter ablation
All AF patients will receive trans catheter ablation by radiofrequency, to destroy arrhythmic atrial cells, and to isolate arrhythmic atrial firing around pulmonary veins' ostia.
Other Name: magnetic resonance of left atrium
- Atrial Fibrillation (AF) recurrence [ Time Frame: 12 months ]Authors will evaluate the percentage of patients in stable sinus rhythm after AF trans catheter ablation.
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): NCT03410966
|Naples, Italy, 80128|
|Principal Investigator:||Celestino Sardu, MD, MSc, PhD||University of Campania "Luigi Vanvitelli"|