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Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294278
Recruitment Status : Unknown
Verified May 2021 by Carlo Pappone, IRCCS Policlinico S. Donato.
Recruitment status was:  Recruiting
First Posted : September 27, 2017
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 10, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Survival from any VA recurrence will be considered as primary endpoint [ Time Frame: 2 years after ablation ]
    NO ventricular arrhythmia recurrence


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294278


Contacts
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Contact: Carlo Pappone, MD +39 02 52774260 carlo.pappone@af-ablation.org

Locations
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Italy
IRCCS Policlinico S. Donato Recruiting
San Donato Milanese, Milano, Italy, 20097
Contact: Carlo Pappone, MD, PhD    00390252774260    carlo.pappone@af-ablation.org   
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Carlo Pappone, MD IRCCS Policlinico San Donato Milan, Italy
More Information
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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: September 27, 2017    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brugada Syndrome
Heart Diseases
Cardiovascular Diseases
 Arrhythmias, Cardiac
Cardiac Conduction System Disease
Genetic Diseases, Inborn