Multicenter Subcutaneous ICD Registry
Sponsor
Universitätsklinikum Köln (Other)
Overall Status
Recruiting
CT.gov ID
NCT04767516
Collaborator
Uniklinik Ulm (Other), St.Barts Hospital, London (Other), VCU Hospital, Richmond (Other), CHU Bordeaux (Other), University Hospital Southampton NHS Foundation Trust (Other), La Fe Hospital Valencia (Other), Med.Hochschule Hannover (Other), EVKLN Duisburg (Other), Veterans Affairs Hospital San Juan (Other), Colorado Childrens Hospital (Other), Stanford Healthcare (Other), Uniklinik Giessen (Other)
600
1
9
66.4
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
600 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Multicenter Registry of Subcutaneous ICD Patients
Actual Study Start Date
:
Apr 1, 2021
Anticipated Primary Completion Date
:
Jan 1, 2022
Anticipated Study Completion Date
:
Jan 1, 2022
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- S/P S-ICD Implantation
Exclusion Criteria:
- n/a
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Cologne | Cologne | NRW | Germany | 50937 |
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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Universitätsklinikum Köln
ClinicalTrials.gov Identifier:
NCT04767516
Other Study ID Numbers:
- 21-1128
First Posted:
Feb 23, 2021
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No