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NCT05643209
Brugada Syndrome Substrate Characterization and Ablation
Conditions: Brugada Syndrome
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Maria Cecilia Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria: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 consentExclusion Criteria: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.
Source: ClinicalTrials.gov (NCT05643209). StuddyBuddy aggregates publicly available trial information.