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AnalyST & Brugada Syndrome - Feasibility Study

Primary Purpose

Brugada Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECG continuous recording (Analyze ST)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brugada Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with Brugada syndrome and previous positive Ajmalin test

Sites / Locations

  • Hopital Laennec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ajmaline test

Arm Description

All patients underwent ajmaline test for ST shift recording

Outcomes

Primary Outcome Measures

ST shift correlation
Correlation between external ECG - ST elevation and device-recorded ST shift. The ajmaline is the reference method to unmask type 1-ECG in Brugada syndrome. During an ajmaline test, both surface ECG and intracardial EGM will be continuously recorded and compared to allow comparison of the signals in terms of amplitude and duration of the ST shift and recovery timing.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2011
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02052765
Brief Title
AnalyST & Brugada Syndrome - Feasibility Study
Official Title
AnalyST & Brugada Syndrome - Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated to the ventricular fibrillation risk of these patients, but there is no mean to record the ECG over a long period of time. The objective of the study is to evaluate the correlation between ST elevation on the electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled in the study are patients already implanted with a defibrillator for their Brugada syndrome. During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG will be compared to assess the detection of the typical ST-shift by the ICD.
Detailed Description
To evaluate the correlation between ST elevation on the ECG and ST shift on the intracardiac EGM recorded with the AnalyST ICD, patients enrolled will have to be already diagnosed as presenting the Brugada Syndrome. They will undergo an ajmaline test, to unmask the type 1-ECG, characteristic from the Brugada syndrome.During the test, both surface ECG and intracardiac signal will be continuously recorded; then the signals will be compared in terms of amplitude of the ST shift, duration of the shift, and recovery period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brugada Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ajmaline test
Arm Type
Experimental
Arm Description
All patients underwent ajmaline test for ST shift recording
Intervention Type
Device
Intervention Name(s)
ECG continuous recording (Analyze ST)
Other Intervention Name(s)
Analyze ST
Intervention Description
During the ajmaline test, continuous ECG recording was forced to record ST shift
Primary Outcome Measure Information:
Title
ST shift correlation
Description
Correlation between external ECG - ST elevation and device-recorded ST shift. The ajmaline is the reference method to unmask type 1-ECG in Brugada syndrome. During an ajmaline test, both surface ECG and intracardial EGM will be continuously recorded and compared to allow comparison of the signals in terms of amplitude and duration of the ST shift and recovery timing.
Time Frame
Acute testing - 4h after the beginning of the ajmaline test.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with Brugada syndrome and previous positive Ajmalin test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Probst, M.D.
Organizational Affiliation
Hopital Laennec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Laennec
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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AnalyST & Brugada Syndrome - Feasibility Study

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