Clinical trial NCT05114772: Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation
Official title: Pre Procedural High Serum Visfatin and Tumor Necrosis Factors "Alpha" Might Predict Recurrent Atrial Fibrillation After Catheter Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 117
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the predictive value of serum levels of adipocytokines and primary phase reactant for recurrent atrial fibrillation (RAF) after catheter ablation in 26 patients had persistent and 91 patients had paroxysmal AF. During 12-m follow-up, 41 patients had RAF (35%). Patients had RAF were significantly older, had significantly higher BMI, lower ejection fraction and wider maximal left atrial diameter (LAD). Serum hs-CRP, IL-6, TNF-α, visfatin, and adiponectin levels were significantly higher in patients developed. Elevated serum levels of TNF-α, visfatin and adiponectin are a significant positive predictors for RAF.

Detailed description: Objectives: Estimation of serum levels of visfatin, adiponectin, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) in patients had atrial fibrillation (AF) resistant to medical treatment and assigned to catheter ablation (CA) to evaluate these biomarkers as predictors for recurrent AF (RAF).

Patients \& Methods: 117 patients; 26 patients had persistent and 91 patients had paroxysmal AF underwent had clinical and echographic evaluations and gave blood samples for ELISA estimation of serum levels of studied cytokines. CA was performed through isolation of all pulmonary veins according to the stepwise procedure of ablation. Patients were re-evaluated every three months till 12-m follow-up for post-procedural RAF.

Eligibility criteria: Inclusion Criteria:

* Symptomatic paroxysmal or persistent AF that was resistant to medical acceptable daily dose therapy in patients who were free of exclusion criteria and accepted to sign the written fully informed consent to undergo CA and to give pre-procedural blood samples.

Exclusion Criteria:

* History of the presence of longstanding persistent or permanent AF,
* myocardial infarction, acute coronary syndrome (ACS),
* significant heart failure (NYHA3),
* dilated or hypertrophic cardiomyopathy,
* left ventricular ejection fraction (LVEF)\< 35%, congenital pathologies,
* significant valvular heart disease,
* pulmonary embolism,
* venous thrombosis,
* intracardiac thrombus or inability to take warfarin or other oral anticoagulants,
* hepatic or renal insufficiency,
* acute inflammatory states (sepsis, chronic obstructive pulmonary disease in acute phase),
* cancer,
* autoimmune pathologies.

Primary outcomes:
measure: Recurrent Atrial Fibrillation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
affiliation: Tanta University
name: Amr El kassas, MD
role: PRINCIPAL_INVESTIGATOR
References: