Multicenter Subcutaneous ICD Registry

January 31, 2023 updated by: Universitätsklinikum Köln

Multicenter Registry of Subcutaneous ICD Patients

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • University Hospital Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an S-ICD

Description

Inclusion Criteria:

  • S/P S-ICD Implantation

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to incidence of explantation through study completion, an average of 5 year
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.
from baseline to incidence of lead failure,through study completion, an average of 5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Battery Longevity
Time Frame: 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.
from baseline to incidence of battery depletion through study completion, an average of 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Köln

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

August 1, 2022

Study Completion (ACTUAL)

August 1, 2022

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (ACTUAL)

February 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21-1128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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