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

Status

Unknown

Conditions

Intervention / Treatment

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

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
Disappearance of type 1 Brugada pattern on post-procedure ECG
24h post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from ventricular arrhythmias
Time Frame: 12 months post-procedure
No documentation of sustained ventricular tachycardia or ventricular fibrillation
12 months post-procedure

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

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.

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