Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation (POLICARDIOFA)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Marker of Inflammation; Arrhythmia; Inflammation; Atrial Fibrillation

Treatments: Diagnostic Test: Markers of inflammation and fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT05961865

6672

Details and patient eligibility

About

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

Full description

The study includes the execution of a sample for each time point for the evaluation of inflammation and fibrosis markers identified so far in the literature, 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.