Clinical trial NCT05961865: Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Official title: Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Marker of Inflammation
Inflammation
Arrhythmia
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2023-07-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Paroxysmal or Persistent Atrial Fibrillation

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.
timeFrame: One year
Secondary outcomes:
measure: Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.
timeFrame: One year
measure: Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.
timeFrame: One year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study officials:
affiliation: IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
name: Stefano Carugo, MD
role: PRINCIPAL_INVESTIGATOR
References: