Characterizing and Ablating Heart Issues in Brugada Syndrome Patients
Brugada Syndrome Substrate Characterization and Ablation: Insights From ECG BrS Type I Pattern, Novel Prognostic Index dST-Tiso and High Density Mapping
NA · Maria Cecilia Hospital · NCT05643209
This study tests if a special heart procedure can help people with Brugada Syndrome who have had serious heart rhythm problems by using advanced mapping to find and treat the areas causing those issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Cecilia Hospital (other) |
| Locations | 1 site (Cotignola, Ravenna) |
| Trial ID | NCT05643209 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of catheter ablation in patients with Brugada Syndrome (BrS) by using advanced mapping techniques to identify and target abnormal heart signals. It focuses on symptomatic patients who have experienced documented episodes of ventricular tachycardia or fibrillation. The approach involves high-density mapping and the use of a contact force catheter for ablation of arrhythmogenic zones in the right ventricular epicardium. The study aims to assess medium to long-term outcomes following the procedure.
Who should consider this trial
Good fit: Ideal candidates include symptomatic adults diagnosed with Brugada Syndrome who have experienced documented ventricular arrhythmias and have an implanted ICD.
Not a fit: Patients who are asymptomatic, have a life expectancy of less than 12 months, or have undergone recent cardiac ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a potential curative treatment option for patients with Brugada Syndrome, reducing the risk of life-threatening arrhythmias.
How similar studies have performed: While there have been limited studies on this approach, the use of radiofrequency ablation for Brugada Syndrome has shown promise, though this specific methodology is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cotignola, Ravenna
- Maria Cecilia Hospital — Cotignola, Ravenna, Italy (RECRUITING)
Study contacts
- Principal investigator: Saverio Iacopino, MD — Maria Cecilia Hospital
- Study coordinator: Saverio Iacopino, MD
- Email: siacopino@gvmnet.it
- Phone: 0545.217228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brugada Syndrome