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

NCT07157449 | Not Yet Recruiting

• 1 other identifier: RC25_0272
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Defibrillator; ECG

Outcome Measures

Primary Outcomes (2)

• 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

  18 months

• 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

  18 months

Study Arms (1)

Identifying electrocardiographic markers on a 12-lead ECG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiology consultation and not having a pacemaker

You may qualify if:

• 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

You may not qualify if:

• Patients receiving cardiac stimulation
• Patient taking part in a therapeutic trial which may interfere with the results of the research
• Patients under guardianship.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Study Officials

• Vincent Probst

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Probst, PU-PH

CONTACT

02 40 16 56 99; vincent.probst@chu-nantes.fr

Probst

CONTACT

bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-07

Locations

FR (1)