RecruitingNot ApplicableNCT05643209

Brugada Syndrome Substrate Characterization and Ablation

Brugada Syndrome Substrate Characterization and Ablation: Insights From ECG BrS Type I Pattern, Novel Prognostic Index dST-Tiso and High Density Mapping


Sponsor

Maria Cecilia Hospital

Enrollment

20 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • 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.

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Interventions

PROCEDUREablation

epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive patients undergoing catheter ablation


Locations(1)

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

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NCT05643209


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