Multicenter Subcutaneous ICD Registry

Universitätsklinikum Köln1,300 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

1,300

Conditions

ICD ICD Malfunction

Interventions

no interventionOTHER

no intervention

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * S/P S-ICD Implantation Exclusion Criteria: * n/a

Locations (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Generator Explantation

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

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

Lead Failure

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

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

Secondary Outcomes

Battery Longevity

Incidence of regular battery depletion. Assessed by medical records and device interrogation.

Time frame: from baseline to incidence of battery depletion through study completion, an average of 5 year

Data from ClinicalTrials.gov

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