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Brugada Syndrome Substrate Characterization and Ablation

RECRUITINGN/ASponsored by Maria Cecilia Hospital
Actively Recruiting
PhaseN/A
SponsorMaria Cecilia Hospital
Started2023-02-01
Est. completion2026-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Brugada SyndromeHeart Disease

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