The SAFE Prospective Registry

University Hospital Ostrava

Status: Enrolling

Conditions: Atrial Fibrillation, Paroxysmal or Persistent

Treatments: Procedure: Catheter ablation and/or electrical cardioversion

Study type: Interventional

Funder types: Other

Identifiers

NCT05794464

FNO-IKK-SAFE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Catheter ablation and/or electrical cardioversion

Experimental group

Description:

Study subjects indicated for catheter ablation and/or electrical cardioversion will be enrolled in this study arm.

Treatment:

Procedure: Catheter ablation and/or electrical cardioversion