S-ICD Electrode Registry

Conditions: ICD Malfunction, Sudden Cardiac Death

Sex: All

Ages: 8 Years – N/A

Enrollment: 1000

Sponsor: Universitätsklinikum Köln

Location: Germany

Summary

The S-ICD is established in the prevention of sudden cardiac death, but recently a defect of the electrode's Sense-B component was reported in some patients. This lead to inadequate shocks due to noise. The cause and incidence of this defect are unknown. The manufacturer issued a warning regarding this defect and a possible premature depletion of the battery in some device. Independent data on the incidence of these issues is limited. Further data is needed to better understand the risk of these complications.

Eligibility Criteria

Inclusion Criteria:status post S-ICD implantationExclusion Criteria:no available follow-up data

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05713708). StuddyBuddy aggregates publicly available trial information.