Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

Sponsor

IRCCS Policlinico S. Donato (Other)

Overall Status

Recruiting

CT.gov ID

NCT03294278

Collaborator

(none)

150

Enrollment

Location

Arms

62.7

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Ventricular Arrhythmias and Cardiac Arrest	Other: ablation plus ICD	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 10, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Survival from any VA recurrence will be considered as primary endpoint [2 years after ablation]
NO ventricular arrhythmia recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico S. Donato	San Donato Milanese	Milano	Italy	20097

Sponsors and Collaborators

IRCCS Policlinico S. Donato

Investigators

Principal Investigator: Carlo Pappone, MD, IRCCS Policlinico San Donato Milan, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlo Pappone, Chief of Arrhythmology Department, IRCCS Policlinico S. Donato

ClinicalTrials.gov Identifier:

NCT03294278

Other Study ID Numbers:

IRCCSDonato Brugada-randomized

First Posted:

Sep 27, 2017

Last Update Posted:

May 18, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brugada Syndrome

Study Results

No Results Posted as of May 18, 2021