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NCT Number: NCT05961865

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Inflammation Marker of Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location status: Recruiting

Location contact

Stefano Carugo, MD

CONTACT

+39 0255033579

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Markers of inflammation and fibrosis

Diagnostic Test

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 outcomes

  1. Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.

    Time frame: 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 outcomes

  1. Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.

    Time frame: 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

  2. Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Carugo, MD

CONTACT

[email protected]

+390255033532

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • University of Milan

Registry information

Acronym: POLICARDIOFA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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