Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation

NCT03757741 | Completed

• 1 other identifier: CM0318-FIR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days. The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring. The secondary endpoints of the study will be:

• rate of re-hospitalization
• rate of survival without relapse
• rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

Conditions

Atrial Fibrillation; Atrial Inflammation

Keywords

atrial fibrillation recurrence; atrial volume; atrial fibrosis; epicardial adipose tissue; inflammatory biomarkers; late gadolinium-enhancement cardiac magnetic resonance; pulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

• The rate of AF recurrence after pulmonary vein isolation

  The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.

  12 months

Secondary Outcomes (3)

• Rate of re-hospitalization

  12 months

• Rate of survival without relapse

  12 months

• Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

  12 months

Study Arms (2)

AF-SG 01

Study subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation

Diagnostic Test: Cardiac imaging tests; Diagnostic Test: Venous blood samle collection

AF-SG 02

Study subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation

Diagnostic Test: Cardiac imaging tests; Diagnostic Test: Venous blood samle collection

Interventions

Cardiac imaging tests DIAGNOSTIC_TEST

2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will

AF-SG 01; AF-SG 02

Venous blood samle collection DIAGNOSTIC_TEST

Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.

AF-SG 01; AF-SG 02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes patients from a single center with paroxysmal and persistent atrial fibrillation, meeting inclusion and exclusion criteria and undergoing pulmonary vein isolation radiofrequency catheter ablation.

You may qualify if:

• Patients with non-valvular paroxysmal or persistent atrial fibrillation who undergo successful ablation of atrial fibrillation, either by cryoablation or by radiofrequency advanced 3D mapping system;
• Ability to provide informed consent;
• Patients aged at least 18 years;

You may not qualify if:

• Patients with valvular atrial fibrillation;
• Patients with acute coronary syndrome in the last 30 days
• Patients in whom atrial fibrillation is presumed to be caused by hyperthyreosis
• Patients with long-standing persistent or permanent atrial fibrillation;
• Unwillingness or incapacity to provide informed consent;
• Allergy to gadolinium contrast media;
• Absolute or relative contraindications to magnetic resonance imaging
• Pregnancy or lactation;
• Women with childbearing potential in absence of any contraceptive treatment
• Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
• Active malignancy or malignancy within the last 5 year prior to enrollment;
• Conditions associated with an estimated life expectancy of under 2 years;

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• University of Targu Mures, Romania: collaborator
• University Hospital of Targu Mures, Romania: collaborator

Study Sites (1)

Cardio Med Medical Center

Târgu Mureş, Mureș County, 540102, Romania

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Szilamér Korodi, M.D.

  University of Medicine and Pharmacy of Tirgu Mures, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 29, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The IPD sharing frame is starting 6 months after publication.

Locations

RO (1)