Characterizing and Ablating Heart Issues in Brugada Syndrome Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using cheek (buccal) cells to detect cell-junction protein changes in inherited arrhythmias

  This project will test whether a painless cheek-swab can reveal the same heart cell-junction protein changes in people with inherited arrhythmias such as arrhythmogenic cardiomyopathy, Brugada syndrome, and other channelopathies.

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• Southeast Asian Brugada Syndrome Group

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• Monitoring fetal heart activity in high-risk pregnancies to prevent stillbirth

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  Recruiting at 2 sites Medical College of Wisconsin · Madison, Wisconsin and 1 other locations · NCT03775954

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.