Brugada SyndromeNCT03435393
Ripple Mapping for Epicardial Mapping of Brugada Syndrome
An observational study of Brugada Syndrome, run by University College London Hospitals at 3 sites in 3 countries.
Trial summary
Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brugada Syndrome
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Sep 2017to Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Brugada syndrome and an episode of ventricular tachycardia
Who may be able to join
- Brugada syndrome patients requiring ablation
Who cannot join
- Patients not able to consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coracao
São Paulo
Mauricio Scanavacca, PhD, +55 11 2661-5000, mauricio.scanavacca@gmail.com
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Cruz
Lisbon
Pedro Adragao, PhD, +351 21 043 1000, padragao@gmail.com
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London
Rui Providencia, PhD, +44207 3777 000., rui_providencia@yahoo.com
About this study
Official title: Ripple-Mapping for the Detection of Long Duration Action Potential Areas in Patients With Brugada Syndrome
Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.
- 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
Mapping of the epicardium and ablating areas of long fractionated potentials
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Brugada syndrome pattern
Disappearance of type 1 Brugada pattern on post-procedure ECG
Measured: 24h post procedure
Secondary outcomes (1)
Freedom from ventricular arrhythmias
No documentation of sustained ventricular tachycardia or ventricular fibrillation
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Sep 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Providência, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435393
- Sponsor's protocol ID
- Barts_Brugada
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be anonymised
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ripple-Mapping for the Detection of Long Duration Action Potential Areas in Patients With Brugada Syndrome
- ClinicalTrials.gov ID
- NCT03435393
- Acronym / sponsor ID
- Barts_Brugada
- Conditions
- Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Feb 2018 (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.
Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Brugada syndrome and an episode of ventricular tachycardia
Key inclusion criteria (1 listed)
- Brugada syndrome patients requiring ablation
Key exclusion criteria (1 listed)
- Patients not able to consent
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 ablationMapping of the epicardium and ablating areas of long fractionated potentials | Procedure or surgery | – |
Primary outcome
Eradication of Brugada syndrome pattern
Time frame: 24h post procedure
Disappearance of type 1 Brugada pattern on post-procedure ECG
1 secondary outcome
Freedom from ventricular arrhythmias
Time frame: 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No. Patient data will be anonymised
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada Syndrome, run by University College London Hospitals at 3 sites in 3 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 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Portugal, United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Brugada syndrome pattern (time frame: 24h post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2018.