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Multicenter Subcutaneous ICD Registry

Multicenter Registry of Subcutaneous ICD Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04767516
Enrollment
1300
Registered
2021-02-23
Start date
2021-04-01
Completion date
2022-08-01
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD, ICD Malfunction

Brief summary

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Uniklinik Ulm
CollaboratorUNKNOWN
St.Barts Hospital, London
CollaboratorUNKNOWN
VCU Hospital, Richmond
CollaboratorUNKNOWN
University Hospital, Bordeaux
CollaboratorOTHER
University Hospital Southampton NHS Foundation Trust
CollaboratorOTHER
Hospital La Fe de Valencia
CollaboratorUNKNOWN
Med.Hochschule Hannover
CollaboratorUNKNOWN
EVKLN Duisburg
CollaboratorUNKNOWN
Veterans Affairs Hospital San Juan
CollaboratorUNKNOWN
Colorado Childrens Hospital
CollaboratorUNKNOWN
Stanford Healthcare
CollaboratorUNKNOWN
Uniklinik Giessen
CollaboratorUNKNOWN
Universitätsklinikum Köln
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* S/P S-ICD Implantation

Exclusion criteria

* n/a

Design outcomes

Primary

MeasureTime frameDescription
Generator Explantationfrom baseline to incidence of explantation through study completion, an average of 5 yearIncidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation.
Lead Failurefrom baseline to incidence of lead failure,through study completion, an average of 5 yearIncidence of S-ICD lead failure. Assessed by medical records and device interrogation.

Secondary

MeasureTime frameDescription
Battery Longevityfrom baseline to incidence of battery depletion through study completion, an average of 5 yearIncidence of regular battery depletion. Assessed by medical records and device interrogation.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026