Brugada Syndrome Substrate Characterization and Ablation
NCT05643209
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
Inclusion Criteria: 1. 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. 2. Patients eligible for ablation with 3D high-density mapping system in accordance with national guidelines, IFU and according to medical decision; 3. Adult patients able to provide written informed consent Exclusion Criteria: 1. Patients unable to provide written informed consent; 2. Patients unable to guarantee their presence at future FU visits; 3. Patients who, according to medical judgment, have a life expectancy of less than 12 months; 4. Patients who have undergone cardiac ablation in the 90 days prior to enrollment. 5. Patients who have had adverse events that have not been resolved after any invasive procedure; 6. Women potentially pregnant or planning to become pregnant.
Conditions2
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NCT05643209