POLICARDIOFA: Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment. [One year]
Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol).
Secondary Outcome Measures
- Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate. [One year]
Identify how many AF patients undergoing ablation have a reduction in related symptoms such as shortness of breath, feeling tired and weakness. The patient will answer an EQ-5D-5L questionnaire for symptom assessment
- Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping. [One year]
Relationship between the degree of inflammation and atrial fibrosis detected through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol) and the degree of atrial fibrosis detected on mapping electroanatomical (voltage map)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Paroxysmal or persistent AF;
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Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures;
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Aged between 18 and 85 years;
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Ability to provide informed consent for study participation.
Exclusion Criteria:
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Age > 85 years or < 18 years;
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Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram;
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NYHA functional class IV;
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Left ventricular ejection fraction <30%;
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Myocardial infarction or unstable angina or recent coronary artery bypass graft (<6 months);
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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;
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Presence of contraindications to the procedure;
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Inability to provide informed consent for study participation.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- University of Milan
Investigators
- Principal Investigator: Stefano Carugo, MD, IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6672