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AnalyST & Brugada Syndrome - Feasibility Study

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ClinicalTrials.gov Identifier: NCT02052765
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : February 4, 2019
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Brugada Syndrome Device: ECG continuous recording (Analyze ST) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: AnalyST & Brugada Syndrome - Feasibility Study
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ajmaline test
All patients underwent ajmaline test for ST shift recording
Device: ECG continuous recording (Analyze ST)
During the ajmaline test, continuous ECG recording was forced to record ST shift
Other Name: Analyze ST

Primary Outcome Measures :
  1. ST shift correlation [ Time Frame: Acute testing - 4h after the beginning of the ajmaline test. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with Brugada syndrome and previous positive Ajmalin test

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): NCT02052765

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Hopital Laennec
Nantes, France, 44000
Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Vincent Probst, M.D. Hopital Laennec
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02052765    
Other Study ID Numbers: CR-10-022-FR-HV
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Brugada Syndrome
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn