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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AnalyST & Brugada Syndrome - Feasibility Study|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
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
- 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.
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
|Nantes, France, 44000|
|Principal Investigator:||Vincent Probst, M.D.||Hopital Laennec|