An observational study in Brugada Syndrome (BrS), Ventricular Arrhythmia and Anesthesia, sponsored by Hospital Clinic of Barcelona. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Hospital Clinic of Barcelona · Observational
The goal of this observational study is to evaluate the perioperative risk of malignant ventricular arrhythmias in adult patients diagnosed with Brugada Syndrome undergoing anaesthetic procedures. Brugada Syndrome is a rare inherited cardiac condition associated with an increased risk of life-threatening arrhythmias, and perioperative management remains challenging due to limited high-quality evidence.
The main questions it aims to answer are:
Researchers will also explore the relative contribution of anaesthetic drugs versus perioperative physiological factors (e.g., haemodynamic changes, fever, bradycardia) in triggering arrhythmias.
Participants will:
This is a multicentre, prospective observational registry, and no additional interventions or changes to standard clinical practice will be performed.
53 studies on the registry are indexed under Brugada Syndrome; 19 are open to participants now.
This study's planned enrollment of 200 is above the median of 155 across 34 observational studies indexed under Brugada Syndrome.
Browse Brugada Syndrome studies →Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult patients with a confirmed diagnosis of Brugada Syndrome receiving care at participating tertiary and secondary hospitals. Patients will be identified through preoperative anaesthesia assessments, hospital admissions, and operating room schedules. The registry will include consecutive patients undergoing any type of anaesthetic procedure (general, locoregional, or sedation) for surgical or non-surgical interventions as part of routine clinical care. Participating centres are expected to include institutions with experience in the perioperative management of cardiac patients, ensuring representation of real-world clinical practice across different healthcare settings.
Patients should match all the inclusion criteria to be entered for data collection:
Patients with one or more exclusion criteria will not be included for data collection and analysis:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (≥18 years) with a confirmed diagnosis of Brugada Syndrome undergoing anaesthetic procedures (general, locoregional, or sedation) for surgical or non-surgical interventions. This is an observational cohort with no assigned interventions. Anaesthetic management, including the use of specific drugs (e.g., propofol, local anaesthetics, ketamine), will be performed according to routine clinical practice. Participants will be followed during the perioperative period and up to 30 days after the procedure to assess the occurrence of malignant ventricular arrhythmias and other clinical outcomes.
Incidence of cardiac arrhytmia from the start of anaesthesia/sedation until 24 hours after the procedure
To determine the incidence of sustained ventricular tachycardia, ventricular fibrillation, arrhythmic cardiac arrest, aborted sudden cardiac death, or appropriate ICD therapy for ventricular arrhythmia from the start of anaesthesia/sedation until 24 hours after the procedure.
Time frame: 24 hours
Intraoperative anesthetic management strategies in BrS patients
Intraoperative anesthetic management strategies in BrS patients, including use of general anaesthesia, monitored sedation, neuraxial and regional techniques across surgical, diagnostic, obstetric and non-surgical settings.
Time frame: During the anesthesic procedure
Peri-procedural complications and relevant ECG changes
To evaluate peri-procedural complications and relevant ECG changes, including dynamic type 1 pattern changes, bradyarrhythmias, supraventricular arrhythmias, haemodynamic instability, fever and electrolyte disturbances.
Time frame: During the anesthesic procedure
Periprocedural complications
To assess ICU/PACU admission rates, unplanned escalation of care, need for car-dioversion/defibrillation, and peri-procedural ICD management.
Time frame: Perioperative
30 days outcome
To analyse 30-day outcomes, including ventricular arrhythmic events, mortality and hospital re-admission
Time frame: 30 days after the anesthesic procedure
Started Jul 2026 (actual). Primary completion is estimated for May 2028, 22 months after the start.
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