Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

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

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).

Study Overview

• Status: Recruiting
• Conditions: Ventricular Arrhythmias and Cardiac Arrest
• Intervention / Treatment: Other: ablation plus ICD

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlo Pappone, MD; Phone Number: +39 02 52774260; Email: carlo.pappone@af-ablation.org

Study Locations

• Italy
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Recruiting
      • IRCCS Policlinico S. Donato
      • Contact: Carlo Pappone, MD, PhD; Phone Number: 00390252774260; Email: carlo.pappone@af-ablation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ablation plus ICD; Epicardial ablation by radio-frequency	Other: ablation plus ICD; Defibrillator, radio-frequency catheter ablation
Active Comparator: ICD alone; Implantation of ICD	Other: ablation plus ICD; Defibrillator, radio-frequency catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival from any VA recurrence will be considered as primary endpoint	NO ventricular arrhythmia recurrence	2 years after ablation

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Investigators: Principal Investigator: Carlo Pappone, MD, IRCCS Policlinico San Donato Milan, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Estimated): September 28, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Brugada Syndrome
• Other Study ID Numbers: IRCCSDonato Brugada-randomized

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No