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Multicenter Subcutaneous ICD Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04767516
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
Uniklinik Ulm
St.Barts Hospital, London
VCU Hospital, Richmond
CHU Bordeaux
University Hospital Southampton NHS Foundation Trust
La Fe Hospital Valencia
Med.Hochschule Hannover
EVKLN Duisburg
Veterans Affairs Hospital San Juan
Colorado Childrens Hospital
Stanford Healthcare
Uniklinik Giessen
Information provided by (Responsible Party):
Universitätsklinikum Köln

Study Description
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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.

Condition or disease Intervention/treatment
ICD ICD Malfunction Other: no intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Registry of Subcutaneous ICD Patients
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022
Groups and Cohorts
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Intervention Details:
  • Other: no intervention
    no intervention

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an S-ICD
Criteria

Inclusion Criteria:

  • S/P S-ICD Implantation

Exclusion Criteria:

  • n/a
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767516


Contacts
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Contact: Jakob Lüker, MD +49221 478 ext 32396 jakob.lueker@uk-koeln.de

Locations
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Germany
University Hospital Cologne Recruiting
Cologne, NRW, Germany, 50937
Contact: Jakob Luker, MD         
Sponsors and Collaborators
Universitätsklinikum Köln
Uniklinik Ulm
St.Barts Hospital, London
VCU Hospital, Richmond
CHU Bordeaux
University Hospital Southampton NHS Foundation Trust
La Fe Hospital Valencia
Med.Hochschule Hannover
EVKLN Duisburg
Veterans Affairs Hospital San Juan
Colorado Childrens Hospital
Stanford Healthcare
Uniklinik Giessen
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT04767516    
Other Study ID Numbers: 21-1128
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No