RecruitingNCT05961865
Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Enrollment
180 participants
Start Date
Jul 11, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria4
- Paroxysmal or persistent AF;
- Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures;
- Aged between 18 and 85 years;
- Ability to provide informed consent for study participation.
Exclusion Criteria8
- Age \> 85 years or \< 18 years;
- Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram;
- NYHA functional class IV;
- Left ventricular ejection fraction \<30%;
- Myocardial infarction or unstable angina or recent coronary artery bypass graft (\<6 months);
- Significant co-morbidity, such as cancer, severe renal failure requiring dialysis, severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than 12 months;
- Presence of contraindications to the procedure;
- Inability to provide informed consent for study participation.
Interventions
DIAGNOSTIC_TESTMarkers of inflammation and fibrosis
Will be analyzed the following inflammation markers: Interleukin 6, N-terminal propeptide of type 1 procollagen (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05961865
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