- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03435393
Ripple Mapping for Epicardial Mapping of Brugada Syndrome
February 15, 2018 updated by: Rui Providência, University College London Hospitals
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil
- Recruiting
- Instituto do Coracao
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Contact:
- Mauricio Scanavacca, PhD
- Phone Number: +55 11 2661-5000
- Email: mauricio.scanavacca@gmail.com
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Lisbon, Portugal
- Recruiting
- Hospital de Santa Cruz
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Contact:
- Pedro Adragao, PhD
- Phone Number: +351 21 043 1000
- Email: padragao@gmail.com
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London, United Kingdom
- Recruiting
- St Bartholomew's Hospital
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Contact:
- Rui Providencia, PhD
- Phone Number: +44207 3777 000.
- Email: rui_providencia@yahoo.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Brugada syndrome and an episode of ventricular tachycardia
Description
Inclusion Criteria:
- Brugada syndrome patients requiring ablation
Exclusion Criteria:
- Patients not able to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eradication of Brugada syndrome pattern
Time Frame: 24h post procedure
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Disappearance of type 1 Brugada pattern on post-procedure ECG
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24h post procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from ventricular arrhythmias
Time Frame: 12 months post-procedure
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No documentation of sustained ventricular tachycardia or ventricular fibrillation
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12 months post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
February 9, 2018
First Submitted That Met QC Criteria
February 9, 2018
First Posted (Actual)
February 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 19, 2018
Last Update Submitted That Met QC Criteria
February 15, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Barts_Brugada
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Patient data will be anonymised
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brugada Syndrome
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Istituto di Fisiologia Clinica CNRAzienda Ospedaliero, Universitaria Pisana; Azienda USL Toscana Nord Ovest; Azienda... and other collaboratorsNot yet recruitingBrugada Syndrome 1Italy
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