Identifying Electrocardiographic Markers to Determine Eligibility for the Implantation of a Subcutaneous Defibrillator.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

The S-ICD defibrillator developed by Boston Scientific Inc. is a fully subcutaneous automatic defibrillation system that prevents and treats sudden cardiac arrest. The subcutaneous system offers the advantage of avoiding the risks associated with transvenous access, limiting serious infections and lead failures. The detection system is based on the identification of rapid ventricular arrhythmias using one of three bipolar vectors defined by the subcutaneous lead (distal and median electrode) and the generator. However, before implanting the device in a patient, it is essential to carry out a screening procedure to ensure that the patient's QRS signal amplitude is sufficient to be detected by the S-ICD. This screening procedure is carried out by recording a specific three-lead electrocardiogram (ECG), which represents the three bipolar vectors of the S-ICD. The aim of this research is to show that the recording of a standard 12-lead ECG can be sufficient to predict the eligibility of patients for S-ICD implantation. More specifically, it aims to identify electrocardiographic markers on a standard 12D-ECG that can be used to determine which patients may benefit from implantation of a subcutaneous defibrillator, thereby eliminating the need for a 3-lead screening ECG. The developments that will be carried out will be based on the development of signal analysis algorithms and decision support using artificial intelligence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient undergoing cardiology consultation, whatever the pathology

Patient over 18 years of age

Patient having been informed and having given their oral non-opposition

Patient and relatives affiliated to a social security scheme

Disqualifiers

Patients receiving cardiac stimulation

Patient taking part in a therapeutic trial which may interfere with the results of the research

Patients under guardianship.

Trial population

Adult patients undergoing cardiology consultation and not having a pacemaker

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Identifying electrocardiographic markers on a 12-lead ECG

Trial outcomes

Primary outcomes

1

to assess the ratio between the size of the R wave corresponding to the depolarization of the ventricles

We will therefore examine for each of the subcutaneous defibrillator detection vectors whether the 12-lead electrocardiogram can determine the success or failure of detection, thus eliminating the need for a 3-lead screening ECG

Time frame
18 months
2

to assess the amplitude of the T wave (ventricular repolarization)

We will therefore examine for each of the subcutaneous defibrillator detection vectors whether the 12-lead electrocardiogram can determine the success or failure of detection, thus eliminating the need for a 3-lead screening ECG

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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