The SAFE Prospective Registry

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation, Paroxysmal or Persistent
• Interventions: Procedure: Catheter ablation and/or electrical cardioversion

• Registration Number: NCT05794464
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-04-03
• Study Start: 2023-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2026-05
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation recurrence based on secretoneurin levels	24 months	Atrial fibrillation recurrence based on secretoneurin levels will be assessed

Secondary Outcome Measures

Name	Time	Method
Brain injury detection	24 months	Brain injury will be detected using serum protein S100B and neuron specific enolase.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia