Multicenter Subcutaneous ICD Registry

Completed

• Conditions: ICD Malfunction; ICD

• Registration Number: NCT04767516
• Lead Sponsor: Universitätsklinikum Köln

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Study Start: 2021-04-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

• S/P S-ICD Implantation

Exclusion Criteria

• n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lead Failure	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	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.

Secondary Outcome Measures

Name	Time	Method
Battery Longevity	from baseline to incidence of battery depletion through study completion, an average of 5 year	Incidence of regular battery depletion. Assessed by medical records and device interrogation.

Trial Locations

Locations (1)

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany