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

Atrial Fibrillation Clinical Trial

— POLICARDIOFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961865
• Other study ID #: 6672
• Status: Recruiting
• Start date: July 11, 2023
• Est. completion date: August 2027

Study information

• Verified date: September 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Stefano Carugo, MD
• Phone: +390255033532
• Email: stefano.carugo[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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