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NCT04767516 Clinical Trial

Multicenter Subcutaneous ICD Registry

ICD Clinical Trial

Official title:
Multicenter Registry of Subcutaneous ICD Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04767516
Other study ID # 21-1128
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date August 1, 2022

Study information
Verified date January 2023
Source Universitätsklinikum Köln
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1300
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - S/P S-ICD Implantation Exclusion Criteria: - n/a

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
Germany University Hospital Cologne Cologne NRW

Sponsors (13)
Lead Sponsor Collaborator
Universitätsklinikum Köln CHU Bordeaux, Colorado Childrens Hospital, EVKLN Duisburg, La Fe Hospital Valencia, Med.Hochschule Hannover, St.Barts Hospital, London, Stanford Healthcare, Uniklinik Giessen, Uniklinik Ulm, University Hospital Southampton NHS Foundation Trust, VCU Hospital, Richmond, Veterans Affairs Hospital San Juan

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Luker J, Strik M, Andrade JG, Raymond-Paquin A, Elrefai MH, Roberts PR, Perez OC, Kron J, Koneru J, Franqui-Rivera H, Sultan A, Ernst A, Schmitt J, Pott A, Veltmann C, Srinivasan NT, Collinson J, van Stipdonk AMW, Linz D, Fluschnik N, Tonnis T, Haeberlin — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Generator Explantation Incidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation. from baseline to incidence of explantation through study completion, an average of 5 year
Primary Lead Failure Incidence of S-ICD lead failure. Assessed by medical records and device interrogation. from baseline to incidence of lead failure,through study completion, an average of 5 year
Secondary Battery Longevity Incidence of regular battery depletion. Assessed by medical records and device interrogation. from baseline to incidence of battery depletion through study completion, an average of 5 year
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