Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05643209). StuddyBuddy aggregates publicly available trial information.