Brugada Syndrome Substrate Characterization and Ablation

Launched by MARIA CECILIA HOSPITAL · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on studying a condition called Brugada Syndrome, which can lead to serious heart problems. The researchers are looking at a specific treatment called catheter ablation, where doctors use special tools to target and remove problematic areas in the heart that can cause abnormal heart rhythms. They aim to see how effective this treatment is over the medium to long term for patients who have already experienced heart issues like ventricular tachycardia (VT) or ventricular fibrillation (VF), both of which are serious heart conditions.

To be eligible for this trial, participants need to be adults diagnosed with certain types of Brugada Syndrome and should have had at least one documented episode of VT or VF in the past year. They should also have a device called an implantable cardioverter-defibrillator (ICD) already placed in their heart. Participants can expect to undergo a thorough mapping of their heart's electrical signals and then receive the catheter ablation treatment. The study is currently recruiting participants, and it’s important for those interested to be able to provide consent and attend follow-up visits after the procedure.

Gender

ALL

Eligibility 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.

Trial Officials