Multicenter Subcutaneous ICD Registry

Overview

This multicenter registry aims to collect data regarding S-ICD longevity, and battery and lead failure rates. Only clinically collected data is gathered in this registry.

Full Title of Study: “Multicenter Registry of Subcutaneous ICD Patients”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2023

Interventions

  • Other: no intervention
    • no intervention

Clinical Trial Outcome Measures

Primary Measures

  • Generator Explantation
    • Time Frame: from baseline to incidence of explantation or end of follow up after 5 years.
    • Incidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation.
  • Lead Failure
    • Time Frame: from baseline to incidence of lead failure, or completion of follow-up duration after 5 years
    • Incidence of S-ICD lead failure. Assessed by medical records and device interrogation.

Secondary Measures

  • Battery Longevity
    • Time Frame: from baseline to incidence of battery depletion, or end of follow up after 5 years
    • Incidence of regular battery depletion. Assessed by medical records and device interrogation.

Participating in This Clinical Trial

Inclusion Criteria

  • S/P S-ICD Implantation Exclusion Criteria:

  • n/a

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Köln
  • Collaborator
    • Uniklinik Ulm
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jakob Lüker, MD, +49221 478, jakob.lueker@uk-koeln.de

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