Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Markers of inflammation and fibrosis.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Marker of Inflammation, Inflammation, Arrhythmia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Markers 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.
Primary outcome measures
- Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment. [Time frame: One year]
Secondary outcome measures (2)
- Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate. [Time frame: One year]
- Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping. [Time frame: One year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan
Identifiers
NCT: NCT05961865 · 6672