AnalyST & Brugada Syndrome - Feasibility Study

• ClinicalTrials.gov Identifier: NCT02052765
• Recruitment Status: Completed
• First Posted: February 3, 2014
• Last Update Posted: February 4, 2019
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Brugada Syndrome	Device: ECG continuous recording (Analyze ST)	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: AnalyST & Brugada Syndrome - Feasibility Study
• Study Start Date: February 2011
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: ajmaline test; All patients underwent ajmaline test for ST shift recording	Device: ECG continuous recording (Analyze ST); During the ajmaline test, continuous ECG recording was forced to record ST shift; Other Name: Analyze ST

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Patients with Brugada syndrome and previous positive Ajmalin test

Contacts and Locations

Locations

France

Hopital Laennec

Nantes, France, 44000

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Principal Investigator: Vincent Probst, M.D.; Hopital Laennec

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02052765
• Other Study ID Numbers: CR-10-022-FR-HV
• First Posted: February 3, 2014
• Last Update Posted: February 4, 2019
• Last Verified: February 2019

Additional relevant MeSH terms:

Brugada Syndrome; Syndrome; Disease; Pathologic Processes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn