Brugada Syndrome Substrate Characterization and Ablation
Recruiting now · Not applicable
Conditions studied: Brugada Syndrome
In brief
Independent, single center, prospective study, to evaluate the efficacy, in consecutive BrS patients undergoing catheter ablation, at medium-long term follow-up after epicardial substrate homogenization. The target area is defined collecting signals using high density and high resolution mapping with equi-spaced electrode array. The ablation of abnormal fragmented prolonged low-frequency ventricular electrograms is performed by contact force catheter.
Key facts
- Study ID
- NCT05643209
- Run by
- Maria Cecilia Hospital
- People needed
- 20
- Starts
- 2023-02-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic patients diagnosed with BrS-ECG pattern of types 1 and 2, both spontaneous and arising after Ajmaline tests, already implanted with an ICD.
- Symptomatic patients are defined as those who present ≥1 documented episode of VT / VF in the 12 months prior to enrollment.
- Patients eligible for ablation with 3D high-density mapping system in accordance with national guidelines, IFU and according to medical decision;
- Adult patients able to provide written informed consent
You may not qualify if…
- Patients unable to provide written informed consent;
- Patients unable to guarantee their presence at future FU visits;
- Patients who, according to medical judgment, have a life expectancy of less than 12 months;
- Patients who have undergone cardiac ablation in the 90 days prior to enrollment.
- Patients who have had adverse events that have not been resolved after any invasive procedure;
- Women potentially pregnant or planning to become pregnant.
Where it is running
- Maria Cecilia Hospital — Cotignola, Ravenna, Italy (enrolling)
Full record on ClinicalTrials.gov
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