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Ablation in Brugada Syndrome for the Prevention of VF (BRAVE)

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ClinicalTrials.gov Identifier: NCT02704416
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute

Brief Summary:
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

Condition or disease Intervention/treatment Phase
Brugada Syndrome Procedure: Catheter Ablation Not Applicable

Detailed Description:
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Prevent Arrhythmia Recurrence
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control arm
Control arm - continued implanted cardioverter defibrillator therapy
Active Comparator: Intervention Arm
ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy
Procedure: Catheter Ablation
catheter ablation of fragmented signal in the right ventricular outflow tract

Single Cross Over Arm
these patients were initially assigned to the control arm of the study. When these patients met the primary outcome of the study it is allowed for these patients to be included in the intervention arm and/or to start quinidine
Procedure: Catheter Ablation
catheter ablation of fragmented signal in the right ventricular outflow tract




Primary Outcome Measures :
  1. Freedom of Ventricular Fibrillation/Tachycardia Recurrences [ Time Frame: 3 year followup ]
    Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge


Secondary Outcome Measures :
  1. Freedom without drug [ Time Frame: 3 years ]
    Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up


Other Outcome Measures:
  1. Quality of life [ Time Frame: 3 years ]
    Improvement or decrease of functional status as measured by RAND 36 QOL questionnaires



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:

  • The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria
  • Diagnosed symptomatic BrS with an implanted ICD within the last 5 years
  • Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years
  • The patient is legally competent, willing and able to undergo the study and signed the informed consent
  • The patient is willing and able to adhere to the follow-up visit protocol

Exclusion Criteria:

  • A patient who does not meet inclusion criteria
  • A patient who has had a previous epicardial ablation
  • A patient who is pregnant (which would exclude an ablation procedure)
  • A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation
  • A patient who has a history of radiation therapy on the thorax

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): NCT02704416


Contacts
Contact: Koonlawee Nademanee, MD 66870708787 koonlawee@pacificrimep.com

Locations
Netherlands
Academic Medical Center, University of Amsterdam Not yet recruiting
Amsterdam, Netherlands
Contact: Pieter G Postema, MD PhD       p.g.postema@amc.nl   
Principal Investigator: Pieter G Postema, MD PhD         
Sub-Investigator: Arthur A Wilde, MD PhD         
Thailand
Bhumipol Adulyadej Hospital, Royal Thai Air Force Recruiting
Bangkok, Thailand
Contact: Gumpanart Veerakul, MD         
Principal Investigator: Gumpanart Veerakul, MD         
Principal Investigator: Koonlawee Nademanee, MD         
Chulalongkorn University Recruiting
Bangkok, Thailand
Contact: Apichai Khong, MD         
Principal Investigator: Apichai Khong, MD         
Pacific Rim Electrophysiology Research Institute Data Coordinating Center Recruiting
Bangkok, Thailand
Contact: Koonlawee Nademanee, MD    66870708787    koonlawee@pacificrimep.com   
Principal Investigator: Koonlawee Nademanee, MD         
Ramathibodi Hospital Recruiting
Bangkok, Thailand
Contact: Tachapong Ngarmukos, MD         
Chiang Mai University Recruiting
Chiang Mai, Thailand
Contact: Wanwarang Wongcharoen, MD    053-289177      
Sponsors and Collaborators
Pacific Rim Electrophysiology Research Institute
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Koonlawee Nademanee, MD Pacific Rim Electrophysiology Research Institute

Publications:
Responsible Party: Koonlawee Nademanee, MD, Principal Investigator, Pacific Rim Electrophysiology Research Institute
ClinicalTrials.gov Identifier: NCT02704416     History of Changes
Other Study ID Numbers: PacificRERI
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Medical journals, abstract submissions and results database

Keywords provided by Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute:
Ventricular arrhythmias
aborted cardiac arrest
cardiac death

Additional relevant MeSH terms:
Syndrome
Brugada Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn