AnalyST & Brugada Syndrome - Feasibility Study

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Patients with Brugada syndrome and previous positive Ajmalin test

Locations
Other Locations
France
Hopital Laennec
Nantes
Time Frame
Start Date: February 2011
Completion Date: May 2011
Participants
Target number of participants: 16
Treatments
Experimental: ajmaline test
All patients underwent ajmaline test for ST shift recording
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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