Multicenter Registry of Subcutaneous ICD Patients

Universitätsklinikum Köln1 site in 1 country1,300 target enrollmentApril 1, 2021

ConditionsICD ICD Malfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ICD
Sponsor: Universitätsklinikum Köln
Enrollment: 1300
Locations: 1
Primary Endpoint: Lead Failure
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

August 1, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Universitätsklinikum Köln

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•S/P S-ICD Implantation

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Lead Failure

Time Frame: from baseline to incidence of lead failure,through study completion, an average of 5 year

Incidence of S-ICD lead failure. Assessed by medical records and device interrogation.

Generator Explantation

Time Frame: from baseline to incidence of explantation through study completion, an average of 5 year

Incidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation.