Registry for patients with subcutaneous implantable cardioverter defibrillators
The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)
This study is looking at how well subcutaneous implantable cardioverter defibrillators work for patients, including their safety and effectiveness, especially for younger and older people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Trial ID | NCT05390047 on ClinicalTrials.gov |
What this trial studies
This multicenter registry aims to evaluate the outcomes of patients who have undergone implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) in a real-world setting. The study focuses on assessing perioperative complication rates, the effectiveness of defibrillation threshold testing, and the outcomes for underrepresented groups such as adolescents and the elderly. Additionally, it will investigate the incidence of inappropriate shocks and the factors influencing these outcomes. The registry will collect data from multiple centers to provide a comprehensive overview of S-ICD performance.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients who have received an S-ICD and have at least one month of follow-up.
Not a fit: Patients who have not undergone S-ICD implantation will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of S-ICD outcomes and improve patient management strategies, potentially reducing complications and inappropriate shocks.
How similar studies have performed: While there have been studies on S-ICD, this registry approach is novel in its comprehensive real-world assessment of outcomes across diverse patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Implantation of an S-ICD, regardless of the technique * At least 1 month of follow up * At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center (e.g. in person visit or remote follow up) Exclusion Criteria: \- none
Where this trial is running
Lübeck, Schleswig-Holstein
- Clinic for Rhythmology — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Julia Vogler, Dr.
- Email: Julia.vogler@uksh.de
- Phone: +49 451 500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.