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Ripple Mapping for Epicardial Mapping of Brugada Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03435393
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 19, 2018
Information provided by (Responsible Party):
Rui Providência, University College London Hospitals

Brief 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.

Condition or disease Intervention/treatment
Brugada Syndrome Procedure: Catheter ablation

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Ripple-Mapping for the Detection of Long Duration Action Potential Areas in Patients With Brugada Syndrome
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Catheter ablation
    Mapping of the epicardium and ablating areas of long fractionated potentials

Primary Outcome Measures :
  1. Eradication of Brugada syndrome pattern [ Time Frame: 24h post procedure ]
    Disappearance of type 1 Brugada pattern on post-procedure ECG

Secondary Outcome Measures :
  1. Freedom from ventricular arrhythmias [ Time Frame: 12 months post-procedure ]
    No documentation of sustained ventricular tachycardia or ventricular fibrillation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Brugada syndrome and an episode of ventricular tachycardia

Inclusion Criteria:

  • Brugada syndrome patients requiring ablation

Exclusion Criteria:

  • Patients not able to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435393

Instituto do Coracao Recruiting
São Paulo, Brazil
Contact: Mauricio Scanavacca, PhD    +55 11 2661-5000    mauricio.scanavacca@gmail.com   
Hospital de Santa Cruz Recruiting
Lisbon, Portugal
Contact: Pedro Adragao, PhD    +351 21 043 1000    padragao@gmail.com   
United Kingdom
St Bartholomew's Hospital Recruiting
London, United Kingdom
Contact: Rui Providencia, PhD    +44207 3777 000.    rui_providencia@yahoo.com   
Sponsors and Collaborators
University College London Hospitals

Responsible Party: Rui Providência, Honorary Consultant, MD PhD, University College London Hospitals
ClinicalTrials.gov Identifier: NCT03435393     History of Changes
Other Study ID Numbers: Barts_Brugada
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will be anonymised

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brugada Syndrome
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn