Brugada SyndromeBRAVENCT02704416
Ablation in Brugada Syndrome for the Prevention of VF
A study testing Catheter Ablation in people with Brugada Syndrome, run by Pacific Rim Electrophysiology Research Institute at 6 sites in 2 countries.
Trial summary
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2016to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Thailand5 sites
Bhumipol Adulyadej Hospital, Royal Thai Air Force
Bangkok
Chulalongkorn University
Bangkok
Pacific Rim Electrophysiology Research Institute Data Coordinating Center
Bangkok
Ramathibodi Hospital
Bangkok
Chiang Mai University
Chiang Mai
Netherlands1 site
Academic Medical Center, University of Amsterdam
Amsterdam
About this study
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
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.
Read the 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.
- Conditions
- Brugada Syndrome
- Being tested
- Catheter Ablation
- Keywords
- Ventricular arrhythmias, aborted cardiac arrest, cardiac death
- Medical subject headings
- Brugada Syndrome, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
catheter ablation of fragmented signal in the right ventricular outflow tract
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Control arm - continued implanted cardioverter defibrillator therapy |
| Intervention Arm | Active comparator | ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy Receives: Procedure: Catheter Ablation |
| Single Cross Over Arm | Other | 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 Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of Ventricular Fibrillation/Tachycardia Recurrences
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge
Measured: 3 year followup
Secondary outcomes (1)
Freedom without drug
Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJul 2016
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brugada SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Rim Electrophysiology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute
- Investigators
- Koonlawee Nademanee, MD, Principal investigator, Pacific Rim Electrophysiology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704416
- Sponsor's protocol ID
- PacificRERI
- Acronym
- BRAVE
- Status last verified
- Nov 2024
- First submitted
- 18 Feb 2016
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Medical journals, abstract submissions and results database
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.
PubMed 26516000Nademanee 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.
PubMed 21403098Ten 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.
PubMed 26480928Wilde 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.
PubMed 26671932
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02704416
- Acronym / sponsor ID
- BRAVE / PacificRERI
- Conditions
- Brugada Syndrome
- Keywords
- Ventricular arrhythmias, aborted cardiac arrest, cardiac death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Pacific Rim Electrophysiology Research InstituteUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Jul 2016
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Control arm - continued implanted cardioverter defibrillator therapy |
| Intervention Arm | Active comparator | Procedure: Catheter Ablationablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy |
| Single Cross Over Arm | Other | Procedure: Catheter Ablationthese 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Ablationcatheter ablation of fragmented signal in the right ventricular outflow tract | Procedure or surgery | Intervention Arm, Single Cross Over Arm |
Primary outcome
Freedom of Ventricular Fibrillation/Tachycardia Recurrences
Time frame: 3 year followup
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge
1 secondary outcome
Freedom without drug
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 26516000Nademanee 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.
- Background: PubMed 21403098Nademanee 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.
- Background: PubMed 26480928Ten 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.
- Background: PubMed 26671932Wilde 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.
- Individual participant dataSharing planned: Yes. Medical journals, abstract submissions and results database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koonlawee Nademanee, MD principal investigator
Pacific Rim Electrophysiology Research Institute
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation in people with Brugada Syndrome, run by Pacific Rim Electrophysiology Research Institute at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Thailand, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of Ventricular Fibrillation/Tachycardia Recurrences (time frame: 3 year followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704416, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.