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

Primary Purpose

Brugada Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Catheter Ablation
Sponsored by
Pacific Rim Electrophysiology Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brugada Syndrome focused on measuring Ventricular arrhythmias, aborted cardiac arrest, cardiac death

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center, University of Amsterdam
  • Bhumipol Adulyadej Hospital, Royal Thai Air ForceRecruiting
  • Chulalongkorn UniversityRecruiting
  • Pacific Rim Electrophysiology Research Institute Data Coordinating CenterRecruiting
  • Ramathibodi HospitalRecruiting
  • Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Other

Arm Label

Control arm

Intervention Arm

Single Cross Over Arm

Arm Description

Control arm - continued implanted cardioverter defibrillator therapy

ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy

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

Outcomes

Primary Outcome Measures

Freedom of Ventricular Fibrillation/Tachycardia Recurrences
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge

Secondary Outcome Measures

Freedom without drug
Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up

Full Information

First Posted
February 18, 2016
Last Updated
April 10, 2022
Sponsor
Pacific Rim Electrophysiology Research Institute
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT02704416
Brief Title
Ablation in Brugada Syndrome for the Prevention of VF
Acronym
BRAVE
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Rim Electrophysiology Research Institute
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brugada Syndrome
Keywords
Ventricular arrhythmias, aborted cardiac arrest, cardiac death

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Control arm - continued implanted cardioverter defibrillator therapy
Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy
Arm Title
Single Cross Over Arm
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation
Intervention Description
catheter ablation of fragmented signal in the right ventricular outflow tract
Primary Outcome Measure Information:
Title
Freedom of Ventricular Fibrillation/Tachycardia Recurrences
Description
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge
Time Frame
3 year followup
Secondary Outcome Measure Information:
Title
Freedom without drug
Description
Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koonlawee Nademanee, MD
Phone
66870708787
Email
koonlawee@pacificrimep.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koonlawee Nademanee, MD
Organizational Affiliation
Pacific Rim Electrophysiology Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter G Postema, MD PhD
Email
p.g.postema@amc.nl
First Name & Middle Initial & Last Name & Degree
Pieter G Postema, MD PhD
First Name & Middle Initial & Last Name & Degree
Arthur A Wilde, MD PhD
Facility Name
Bhumipol Adulyadej Hospital, Royal Thai Air Force
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gumpanart Veerakul, MD
First Name & Middle Initial & Last Name & Degree
Gumpanart Veerakul, MD
First Name & Middle Initial & Last Name & Degree
Koonlawee Nademanee, MD
Facility Name
Chulalongkorn University
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Apichai Khong, MD
First Name & Middle Initial & Last Name & Degree
Apichai Khong, MD
Facility Name
Pacific Rim Electrophysiology Research Institute Data Coordinating Center
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koonlawee Nademanee, MD
Phone
66870708787
Email
koonlawee@pacificrimep.com
First Name & Middle Initial & Last Name & Degree
Koonlawee Nademanee, MD
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tachapong Ngarmukos, MD
Facility Name
Chiang Mai University
City
Chiang Mai
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanwarang Wongcharoen, MD
Phone
053-289177

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Medical journals, abstract submissions and results database
Citations:
PubMed Identifier
26516000
Citation
Nademanee K, Raju H, de Noronha SV, Papadakis M, Robinson L, Rothery S, Makita N, Kowase S, Boonmee N, Vitayakritsirikul V, Ratanarapee S, Sharma S, van der Wal AC, Christiansen M, Tan HL, Wilde AA, Nogami A, Sheppard MN, Veerakul G, Behr ER. Fibrosis, Connexin-43, and Conduction Abnormalities in the Brugada Syndrome. J Am Coll Cardiol. 2015 Nov 3;66(18):1976-1986. doi: 10.1016/j.jacc.2015.08.862.
Results Reference
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PubMed Identifier
21403098
Citation
Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior right ventricular outflow tract epicardium. Circulation. 2011 Mar 29;123(12):1270-9. doi: 10.1161/CIRCULATIONAHA.110.972612. Epub 2011 Mar 14.
Results Reference
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PubMed Identifier
26480928
Citation
Ten Sande JN, Coronel R, Conrath CE, Driessen AH, de Groot JR, Tan HL, Nademanee K, Wilde AA, de Bakker JM, van Dessel PF. ST-Segment Elevation and Fractionated Electrograms in Brugada Syndrome Patients Arise From the Same Structurally Abnormal Subepicardial RVOT Area but Have a Different Mechanism. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1382-92. doi: 10.1161/CIRCEP.115.003366. Epub 2015 Oct 19.
Results Reference
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PubMed Identifier
26671932
Citation
Wilde AA, Nademanee K. Epicardial Substrate Ablation in Brugada Syndrome: Time for a Randomized Trial! Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1306-8. doi: 10.1161/CIRCEP.115.003500. No abstract available.
Results Reference
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Ablation in Brugada Syndrome for the Prevention of VF

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