NCT07157449 Identifying Electrocardiographic Markers to Determine Eligibility for the Implantation of a Subcutaneous Defibrillator.
| NCT ID | NCT07157449 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Defibrillator |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-01-27 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria : * 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 Exclusion Criteria : * Patients receiving cardiac stimulation * Patient taking part in a therapeutic trial which may interfere with the results of the research * Patients under guardianship.
Contact & Investigator
Vincent Probst
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT07157449 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Defibrillator. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07157449 currently recruiting?
Yes, NCT07157449 is actively recruiting participants. Contact the research team at vincent.probst@chu-nantes.fr for enrollment information.
Where is the NCT07157449 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT07157449 clinical trial?
NCT07157449 is sponsored by Nantes University Hospital. The principal investigator is Vincent Probst at Nantes University Hospital. The trial plans to enroll 1,000 participants.