Brugada Syndrome Substrate Characterization and Ablation
ConditionBrugada Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Cecilia Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Symptomatic patients diagnosed with BrS-ECG pattern of types 1 and 2, both spontaneous and arising after Ajmaline tests, already implanted with an ICD.
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
ablation
Procedure/Surgeryepicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive patients undergoing catheter ablation
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: consecutive patientsOther 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.
The primary aim of the study is the rate of success at medium-long term follow-up after epicardial substrate homogenization (ablating abnormal fragmented prolonged low-frequency ventricular electrograms) in consecutive brugada patients undergoing catheter ablation. The medium-long term success of the ablation is defined in terms of percentage of patients free from any clinical ventricular arrhythmia at a 3, 6-months and 12-months follow-up from the procedure.
Time frame
12-monthsSecondary outcomes
1
Collecting and analyzing data concerning late potential and voltage maps using different settings, vector data and speed maps, could be useful to better understand and describe the mechanism of this pathology.
• Comparison among different setting of voltage map (OT vs Standard acquisition)
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov