Atrial Fibrillation Ablation
NCT03410966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2018-01-26
Summary
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.
Conditions
- Atrial Fibrillation
- Heart Failure, Diastolic
Interventions
- 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.
Sponsors & Collaborators
-
University of Campania Luigi Vanvitelli
lead OTHER
Principal Investigators
-
Celestino Sardu, MD, MSc, PhD · University of Campania Luigi Vanvitelli
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-01
- Primary Completion
- 2017-01-01
- Completion
- 2017-11-01
Countries
- Italy
Study Locations
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