Evaluating inflammation changes in patients after heart rhythm procedure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the relationship between inflammation markers and local fat levels in patients undergoing catheter ablation for atrial fibrillation. It will analyze various inflammation and fibrosis markers, including Interleukin 6 and tumor necrosis factor, at different time points before and after the procedure. The study will include patients aged 18 to 85 who meet specific clinical criteria and can provide informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Stefano Carugo, MD — IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
• Study coordinator: Stefano Carugo, MD
• Email: stefano.carugo@policlinico.mi.it
• Phone: +390255033532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.