Status:
COMPLETED
Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation
Lead Sponsor:
Cardio Med Medical Center
Collaborating Sponsors:
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania
Conditions:
Atrial Fibrillation
Atrial Inflammation
Eligibility:
All Genders
18+ years
Brief Summary
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammat...
Detailed Description
The prevalence of atrial fibrillation (AF) is on the rise, being the most frequent sustained supraventricular arrhythmia and a health issue by its increased morbidity and mortality. In most of the cas...
Eligibility Criteria
Inclusion
- Patients with non-valvular paroxysmal or persistent atrial fibrillation who undergo successful ablation of atrial fibrillation, either by cryoablation or by radiofrequency advanced 3D mapping system;
- Ability to provide informed consent;
- Patients aged at least 18 years;
Exclusion
- Patients with valvular atrial fibrillation;
- Patients with acute coronary syndrome in the last 30 days
- Patients in whom atrial fibrillation is presumed to be caused by hyperthyreosis
- Patients with long-standing persistent or permanent atrial fibrillation;
- Unwillingness or incapacity to provide informed consent;
- Allergy to gadolinium contrast media;
- Absolute or relative contraindications to magnetic resonance imaging
- Pregnancy or lactation;
- Women with childbearing potential in absence of any contraceptive treatment
- Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
- Active malignancy or malignancy within the last 5 year prior to enrollment;
- Conditions associated with an estimated life expectancy of under 2 years;
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03757741
Start Date
February 1 2019
End Date
February 1 2022
Last Update
August 2 2022
Active Locations (1)
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1
Cardio Med Medical Center
Târgu Mureş, Mureș County, Romania, 540102