UZ Brussel HRMC Registry of Brugada Syndrome

Brugada Syndrome Clinical Trial

— HRMCBrS  

Official title:

UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283759
• Other study ID #: UZ Brussel Brugada registry
• Status: Recruiting
• Start date: January 1, 1992
• Est. completion date: January 1, 2032

Study information

• Verified date: March 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: Carlo de Asmundis, MD, PhD
• Phone: +32024763704
• Email: hrmc[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).

Description:

The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome.

These includes:

1. demographical data: age, sex

2. antropometric data: height, weight, BMI

3. clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy

3) data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2032
• Est. primary completion date: January 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Brugada syndrome diagnosis

Exclusion Criteria:

• Other diagnosis different from Brugada syndrome

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

Other:
• No intervention because it is a patient registry

Locations

Country	Name	City	State
Belgium	UZ Brussel Heart Rhythm Management Center	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular arrhythmias	Composite of: sudden cardiac death, aborted sudden cardiac death, ventricular fibrillation, sustained ventricular tachycardia, ICD appropriate therapy	through study completion, an average of 10 year
Primary	Atrial fibrillation	Atrial fibrillation occurrence	through study completion, an average of 10 year
Primary	Death for any cause	Death for any cause	through study completion, an average of 10 year
Primary	Cardiovascular death	Death for cardiovascular cause	through study completion, an average of 10 year
Primary	Genetic mutations	Genetic mutations (pathogenic and variant of unknown significance) associated with Brugada syndrome. Wide gene panel with next generation sequencing will be used: Roche SeqCap® EZ Human Exome Probes v3.0 for BrS.	Baseline