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AnalyST & Brugada Syndrome - Feasibility Study

NCT02052765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-02-04

No results posted yet for this study

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.

Conditions

  • Brugada Syndrome

Interventions

DEVICE

ECG continuous recording (Analyze ST)

During the ajmaline test, continuous ECG recording was forced to record ST shift

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Vincent Probst, M.D. · Hopital Laennec

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02052765 on ClinicalTrials.gov