The SAFE Prospective Registry

Study Overview
=================
Brief Summary
-----------------
Secretoneurin (SN) is a neuropeptide from the chromogranin family that influences intracellular calcium handling. SN suppresses calcium leakage from the sarcoplasmic reticulum through the ryanodine receptor. SN is a novel biomarker that has shown the potential to predict adverse arrhythmic events.

Detailed Description
-----------------
The aim of the study is to sample SN before and after catheter ablation (CA) for atrial fibrillation (Afib) to predict the recurrence after CA. Also, the uric acid/albumin ratio will be assessed as a marker of Afib recurrence. Since the uric acid/albumin ratio has been shown to be predictive of Afib in patients with myocardial infarction moreover incidence of atrial fibrillation is higher in patients with gout. As a side branch marker for silent brain injury, neuron-specific enolase (NSE) and protein S100B will be evaluated. NSE showed in small trials a significant increase after catheter ablation, as well as S100B. The prognostic power is not clear yet. From the systematic review, the most powerful predictors seem to be N-terminal (NT)-prohormone B-type natriuretic peptide (NT-Pro-BNP/BNP), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and Carboxy-terminal telopeptide of collagen type I. Biomarkers are divided into 3 main types: congestion, inflammation, and renal function. Patients will be enrolled before catheter ablation/electrical cardioversion for Afib after signing IS, and the blood sampling will be performed the day before and the day after catheter ablation. In the electric cardioversion arm, the blood sampling will be performed before electrical cardioversion and 2h after the cardioversion before discharge. Patients will be followed for recurrency - all patients will have a 24-hour ECG Holter and External loop recorder (MDT) for two weeks after the three months of the blanking period. Clinical outpatient control will ensue in the 4th, eighth,12, and 24 months.

Official Title
-----------------
Secretoneurin as a Biomarker of Atrial Fibrillation rEcurrence After Catheter Ablation/Electrical Cardioversion

Conditions
-----------------
Atrial Fibrillation, Paroxysmal or Persistent

Intervention / Treatment
-----------------
* Procedure: Catheter ablation and/or electrical cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation (Afib); (paroxysmal, persistent) Patients indicated for catheter ablation and/or electrical cardioversion Signed informed consent Exclusion Criteria: Longstanding or permanent atrial fibrillation Severe mitral regurgitation Heart failure with a permanently reduced ejection fraction Cerebral ischaemic stroke in < 3 months Severe kidney injury Severe renal insufficiency Hepatic insufficiency limiting biomarker sampling Myocardial infarction < 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study subjects will be enrolled in one group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter ablation and/or electrical cardioversion<br>Study subjects indicated for catheter ablation and/or electrical cardioversion will be enrolled in this study arm. | Procedure: Catheter ablation and/or electrical cardioversion<br>* Catheter ablation and/or electrical cardio version are procedures intended to treat atrial fibrillation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation recurrence based on secretoneurin levels | Atrial fibrillation recurrence based on secretoneurin levels will be assessed | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain injury detection | Brain injury will be detected using serum protein S100B and neuron specific enolase. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, secretoneurin, catheter ablation, electrical cardio version