Brugada SyndromeBRAVONCT04420078
Brugada Ablation of VF Substrate Ongoing MultiCenter Registry
An observational study of Brugada Syndrome, run by Pacific Rim Electrophysiology Research Institute at 1 site in Thailand.
Trial summary
Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term outcomes of CA in BrS ablation are lacking. 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
- How many people
- 159 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2017to 1 Dec 2023
- Phase
- Observational
- 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
Study population: Patients who have positive Brugada ECG pattern and have underwent catheter ablation of VF substrates prior to enrollment.
Who may be able to join
- Symptomatic Brugada Syndrome patients who had undergone catheter ablation of the arrhythmogenic substrates.
Who cannot join
- Patients who will not commit to regular follow up.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Pacific Rim Electrophysiology Research Institute, Chulalongkorn University
Bangkok
About this study
Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term outcomes of CA in BrS ablation are lacking.
Read the detailed description
Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for catheter ablations of complex arrhythmias from three continents - Asia, Europe and North America - are registered in a common database. The investigators exclude patients who were lost to follow up in the outpatient clinic.
- Conditions
- Brugada Syndrome
- Being tested
- Catheter Ablation
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
Ventricular fibrillation substrate
| Study group | Role | What they receive |
|---|---|---|
| CA BrS | Symptomatic BrS patients who underwent catheter ablation of the BrS/VF substrate Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Expiration, unrelated to procedure
Measured: 3 years
ICD Therapy for VT/VF
Electrical therapy delivered through device for termination of VF episodes
Measured: 3 years
Secondary outcomes (2)
Inappropriate ICD Therapy
Caused by lead sensing or programming errors
Measured: 3 years
Normalization of Brugada ECG pattern
ECG pattern is normal sinus rhythm after catheter ablation
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 posted9 Jun 2020
- Study start1 Jul 2017
- Primary completion28 Feb 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Rim Electrophysiology Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University of Tsukuba, University of London, University of Amsterdam, Ogaki Municipal Hospital, Indiana University, Taipei Veterans General Hospital, Taiwan, Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420078
- Sponsor's protocol ID
- BRAVO Registry
- Acronym
- BRAVO
- Status last verified
- Nov 2024
- First submitted
- 18 May 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data published will be deindentified
Publications
Nademanee K, Chung FP, Sacher F, Nogami A, Nakagawa H, Jiang C, Hocini M, Behr E, Veerakul G, Jan Smit J, Wilde AAM, Chen SA, Yamashiro K, Sakamoto Y, Morishima I, Das MK, Khongphatthanayothin A, Vardhanabhuti S, Haissaguerre M. Long-Term Outcomes of Brugada Substrate Ablation: A Report from BRAVO (Brugada Ablation of VF Substrate Ongoing Multicenter Registry). Circulation. 2023 May 23;147(21):1568-1578. doi: 10.1161/CIRCULATIONAHA.122.063367. Epub 2023 Mar 24.
PubMed 36960730
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
- Brugada Ablation of VF Substrate Ongoing MultiCenter Registry
- ClinicalTrials.gov ID
- NCT04420078
- Acronym / sponsor ID
- BRAVO / BRAVO Registry
- Conditions
- Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Pacific Rim Electrophysiology Research InstituteUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University of Tsukuba, University of London, University of Amsterdam, Ogaki Municipal Hospital, Indiana University, Taipei Veterans General Hospital, Taiwan, Zhejiang University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 9 Jun 2020 (actual)
- 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.
Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term outcomes of CA in BrS ablation are lacking.
Detailed description
Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for catheter ablations of complex arrhythmias from three continents - Asia, Europe and North America - are registered in a common database. The investigators exclude patients who were lost to follow up in the outpatient clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CA BrS | – | Procedure: Catheter AblationSymptomatic BrS patients who underwent catheter ablation of the BrS/VF substrate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have positive Brugada ECG pattern and have underwent catheter ablation of VF substrates prior to enrollment.
Key inclusion criteria (1 listed)
- Symptomatic Brugada Syndrome patients who had undergone catheter ablation of the arrhythmogenic substrates.
Key exclusion criteria (1 listed)
- Patients who will not commit to regular follow up.
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 AblationVentricular fibrillation substrate | Procedure or surgery | CA BrS |
Primary outcome
Death
Time frame: 3 years
Expiration, unrelated to procedure
ICD Therapy for VT/VF
Time frame: 3 years
Electrical therapy delivered through device for termination of VF episodes
2 secondary outcomes
Inappropriate ICD Therapy
Time frame: 3 years
Normalization of Brugada ECG pattern
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.
- Derived from this study: PubMed 36960730Nademanee K, Chung FP, Sacher F, Nogami A, Nakagawa H, Jiang C, Hocini M, Behr E, Veerakul G, Jan Smit J, Wilde AAM, Chen SA, Yamashiro K, Sakamoto Y, Morishima I, Das MK, Khongphatthanayothin A, Vardhanabhuti S, Haissaguerre M. Long-Term Outcomes of Brugada Substrate Ablation: A Report from BRAVO (Brugada Ablation of VF Substrate Ongoing Multicenter Registry). Circulation. 2023 May 23;147(21):1568-1578. doi: 10.1161/CIRCULATIONAHA.122.063367. Epub 2023 Mar 24.
- Individual participant dataSharing planned: No. All data published will be deindentified
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by Pacific Rim Electrophysiology Research Institute at 1 site in Thailand.
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 1 inclusion and 1 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 1 site in Thailand. 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?
Death (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT04420078, which also lists 1 linked publication.
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.