AnalyST & Brugada Syndrome - Feasibility Study

Brugada Syndrome Clinical Trial

Official title:

AnalyST & Brugada Syndrome - Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052765
• Other study ID #: CR-10-022-FR-HV
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Brugada syndrome and previous positive Ajmalin test

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

Device:
• ECG continuous recording (Analyze ST)
During the ajmaline test, continuous ECG recording was forced to record ST shift

Locations

Country	Name	City	State
France	Hopital Laennec	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.