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Clinical Trials in Italy / NCT05961865
Recruiting Observational

Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation

NCT05961865 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase
Observational
Started
2023-07-11
Last updated
2023-09-13

Condition(s) studied

Atrial FibrillationMarker of InflammationInflammationArrhythmia

Investigational drug(s) / intervention(s)

Markers of inflammation and fibrosis

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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).

Trial sites (1)

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

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Other trials for the same condition

A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
AF Ablation With High Power Short Duration RF Recruiting
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation Active, not recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting
Diamagnetic Therapy in Pain and Inflammation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05961865 on ClinicalTrials.gov ↗ ← All trials in Italy