Hybrid mini-thoracotomy for Brugada syndrome: epicardial substrate characterization and ablation-results from UNCOVER(BrS) study.
Saverio Iacopino, Paolo Francesco Sorrenti, Andrea Petretta...
https://pubmed.ncbi.nlm.nih.gov/41229453Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05643209
Brugada Syndrome Substrate Characterization and Ablation: Insights From ECG BrS Type I Pattern, Novel Prognostic Index dST-Tiso and High Density Mapping
Led by Maria Cecilia Hospital · Updated on 2025-08-15
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Brugada Syndrome (BrS), a heart condition that can cause dangerous irregular heartbeats, especially in patients who may not show symptoms at diagnosis. This study aims to evaluate the effectiveness of a catheter ablation procedure at medium to long-term follow-up in patients with BrS. The procedure targets abnormal heart signals detected using a high-density, high-resolution electrode array to better understand and treat the arrhythmogenic substrate associated with BrS. The study also investigates a new measurement called the dST-Tiso interval, which may predict the risk of arrhythmias in these patients. The treatment involves epicardial substrate homogenization by ablating abnormal fragmented prolonged low-frequency ventricular electrograms using a contact force catheter guided by detailed electrical mapping. This catheter ablation is performed in patients who have already had an implantable cardioverter defibrillator (ICD) and documented ventricular arrhythmias. The study collects data on heart electrical activity using advanced mapping tools and evaluates changes after the ablation procedure. The procedure aims to improve the definition of abnormal heart areas and may confirm links with specific ECG features. Participants will be monitored at 3, 6, and 12 months after the ablation procedure to assess freedom from ventricular arrhythmias. The study collects detailed electrical maps, vector data, and speed maps to help understand BrS mechanisms. Patients undergo regular follow-up visits where heart function and arrhythmia status are assessed. The study tracks long-term outcomes related to heart rhythm safety and effectiveness of the ablation approach. The total participation duration covers at least one year of follow-up after treatment.
CONDITIONS
Brief Title
Brugada Syndrome Substrate Characterization and Ablation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Symptomatic patients diagnosed with Brugada Syndrome ECG pattern types 1 and 2, either spontaneous or after Ajmaline tests, with an implanted ICD
- Patients who have had at least one documented episode of ventricular tachycardia or ventricular fibrillation in the 12 months before enrollment
- Patients eligible for ablation using a 3D high-density mapping system according to guidelines and medical decision
- Adult patients able to provide written informed consent
You will not qualify if you...
- Patients unable to provide written informed consent
- Patients unable to guarantee attendance at future follow-up visits
- Patients with a life expectancy less than 12 months as judged by medical staff
- Patients who had cardiac ablation within 90 days before enrollment
- Patients with unresolved adverse events from any previous invasive procedure
- Women who are pregnant or planning to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 day
Participants undergo epicardial substrate homogenization by ablating abnormal fragmented prolonged low-frequency ventricular electrograms using a catheter-based mapping procedure.
1 procedure visit (in-person)
Follow-up
Duration - 12 months
Participants are monitored to assess the efficacy of the ablation procedure and to collect data concerning late potential and voltage maps, vector data, and speed maps to better understand the pathology.
Visits at 3, 6, and 12 months post-procedure (in-person)
Trial Site Locations
Total: 1 location
1
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48033
Actively Recruiting
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Research Team
S
Saverio Iacopino, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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