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Clinical Trials in Italy / NCT05643209
Recruiting Not applicable

Brugada Syndrome Substrate Characterization and Ablation

NCT05643209 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-02-01
Last updated
2025-08-15

Condition(s) studied

Brugada Syndrome

Investigational drug(s) / intervention(s)

ablation

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Maria Cecilia Hospital Cotignola Ravenna Recruiting

More Maria Cecilia Hospital trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05643209 on ClinicalTrials.gov ↗ ← All trials in Italy