BRAVE: Ablation in Brugada Syndrome for the Prevention of VF
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
| Other: 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
|
Outcome Measures
Primary Outcome Measures
- Freedom of Ventricular Fibrillation/Tachycardia Recurrences [3 year followup]
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge
Secondary Outcome Measures
- Freedom without drug [3 years]
Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria
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Diagnosed symptomatic BrS with an implanted ICD within the last 5 years
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Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years
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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:
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A patient who does not meet inclusion criteria
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A patient who has had a previous epicardial ablation
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A patient who is pregnant (which would exclude an ablation procedure)
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A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation
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A patient who has a history of radiation therapy on the thorax
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Academic Medical Center, University of Amsterdam | Amsterdam | Netherlands | ||
| 2 | Bhumipol Adulyadej Hospital, Royal Thai Air Force | Bangkok | Thailand | ||
| 3 | Chulalongkorn University | Bangkok | Thailand | ||
| 4 | Pacific Rim Electrophysiology Research Institute Data Coordinating Center | Bangkok | Thailand | ||
| 5 | Ramathibodi Hospital | Bangkok | Thailand | ||
| 6 | Chiang Mai University | Chiang Mai | Thailand |
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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- PacificRERI