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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05961865
Other study ID # 6672
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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