Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation (POLICARDIOFA)

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

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Atrial Fibrillation; Arrhythmia; Marker of Inflammation
• Intervention / Treatment: Diagnostic test: Markers of inflammation and fibrosis

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 Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Stefano Carugo, MD; Phone Number: +390255033532; Email: stefano.carugo@policlinico.mi.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    • Contact: Stefano Carugo, MD; Phone Number: +39 0255033579

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Paroxysmal or Persistent Atrial Fibrillation

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.	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).	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.	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	One year
Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.	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)	One year

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: University of Milan
• Investigators: Principal Investigator: Stefano Carugo, MD, IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Inflammation; Atrial Fibrillation
• Other Study ID Numbers: 6672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No