Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

Ventricular Arrhythmias and Cardiac Arrest Clinical Trial

Official title:

Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03294278
• Other study ID #: IRCCSDonato Brugada-randomized
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Carlo Pappone, MD
• Phone: +39 02 52774260
• Email: carlo.pappone[@]af-ablation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Description:

The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).

Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.

A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS

• Consensus document criteria

• The patient received at least 1 appropriate ICD shock.

• Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden >10000;

• Age = 18;

• Willingness to attend follow-up examinations;

• Written informed consent for participation in the trial.

Exclusion Criteria:

• A patient who does not meet inclusion criteria;

• Pregnancy or breast-feeding (which would exclude an ablation procedure);

• Contraindications to general anesthesia or epicardial ablation;

• Life expectancy < 12 months

Related Conditions & MeSH terms

• Brugada Syndrome
• Ventricular Arrhythmias and Cardiac Arrest

Intervention

Other:
• ablation plus ICD
Defibrillator, radio-frequency catheter ablation

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival from any VA recurrence will be considered as primary endpoint	NO ventricular arrhythmia recurrence	2 years after ablation