Actively Recruiting
Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2023-09-13
180
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead Sponsor
U
University of Milan
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study focuses on patients with paroxysmal or persistent atrial fibrillation (AF) undergoing catheter ablation. The main aim is to explore how inflammation markers relate to local fat deposits, clinical risk factors, and changes after AF ablation. Researchers want to better understand the link between inflammation and heart tissue changes in this condition. The study involves collecting blood samples at various times to measure inflammation and fibrosis markers such as Interleukin 6, N-terminal propeptide of procollagen type 1 (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. These markers are analyzed to assess changes before and after the ablation procedure. Participants will be monitored over one year to evaluate reductions in inflammation and improvements in clinical outcomes including arrhythmia recurrence. The study includes clinical evaluations, blood tests for biomarkers, and electroanatomical mapping to assess atrial fibrosis. The research team will track how inflammation levels correspond with heart tissue changes and patient recovery during this period.
CONDITIONS
Brief Title
Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of paroxysmal or persistent atrial fibrillation
- Scheduled for catheter ablation procedure approved by the European Society of Cardiology/European Heart Rhythm Association
- Age between 18 and 85 years
- Ability to provide informed consent to participate
You will not qualify if you...
- Age under 18 years or over 85 years
- Presence of left auricular thrombosis detected by pre-procedural transesophageal echocardiogram
- New York Heart Association (NYHA) functional class IV
- Left ventricular ejection fraction below 30%
- Recent myocardial infarction, unstable angina, or coronary artery bypass graft within 6 months
- Serious co-morbidities such as cancer, severe renal failure requiring dialysis, severe obstructive pulmonary disease, or cirrhosis with life expectancy less than 12 months
- Contraindications to the ablation procedure
- Inability to provide informed consent for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo sampling at multiple time points to evaluate markers of inflammation and fibrosis associated with atrial fibrillation.
Multiple sample collections during and after the ablation procedure
Duration - Up to 1 year
Participants are monitored for changes in inflammatory burden, clinical improvement, and arrhythmia recurrence following catheter ablation.
Periodic follow-up assessments over one year
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
Research Team
S
Stefano Carugo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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