NCT02052765

AnalyST & Brugada Syndrome - Feasibility Study

Completed NA Last updated 1 February 2019

What this trial tests

NA trial testing ECG continuous recording (Analyze ST) in Brugada Syndrome in 16 participants. Completed in 1 May 2011.

Timeline

1 February 2011

Primary endpoint
1 May 2011

1 May 2011

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	1 February 2011
Primary completion	1 May 2011
Estimated completion	1 May 2011
Sites	1 location across France

Drugs / interventions tested

• ECG continuous recording (Analyze ST)

Conditions studied

• Brugada Syndrome — all drugs for Brugada Syndrome →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Brugada Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.