AnalyST & Brugada Syndrome - Feasibility Study
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 19, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2014
CompletedFebruary 4, 2019
February 1, 2019
3 months
September 19, 2011
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Acute testing - 4h after the beginning of the ajmaline test.
Study Arms (1)
ajmaline test
EXPERIMENTALAll patients underwent ajmaline test for ST shift recording
Interventions
During the ajmaline test, continuous ECG recording was forced to record ST shift
Eligibility Criteria
You may qualify if:
- Patients with Brugada syndrome and previous positive Ajmalin test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Laennec
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Probst, M.D.
Hopital Laennec
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2011
First Posted
February 3, 2014
Study Start
February 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
February 4, 2019
Record last verified: 2019-02