Multicenter Subcutaneous ICD Registry
Multicenter Registry of Subcutaneous ICD Patients
1 other identifier
observational
1,300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFebruary 2, 2023
January 1, 2023
1.3 years
February 11, 2021
January 31, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Battery Longevity
from baseline to incidence of battery depletion through study completion, an average of 5 year
Interventions
no intervention
Eligibility Criteria
Patients with an S-ICD
You may qualify if:
- S/P S-ICD Implantation
You may not qualify if:
- n/a
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Kölnlead
- Uniklinik Ulmcollaborator
- St.Barts Hospital, Londoncollaborator
- VCU Hospital, Richmondcollaborator
- University Hospital, Bordeauxcollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
- Hospital La Fe de Valenciacollaborator
- Med.Hochschule Hannovercollaborator
- EVKLN Duisburgcollaborator
- Veterans Affairs Hospital San Juancollaborator
- Colorado Childrens Hospitalcollaborator
- Stanford Healthcarecollaborator
- Uniklinik Giessencollaborator
Study Sites (1)
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937, Germany
Related 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 A, Ploux S, Steven D. Incidence of premature battery depletion in subcutaneous cardioverter-defibrillator patients: insights from a multicenter registry. J Interv Card Electrophysiol. 2025 Oct;68(7):1409-1415. doi: 10.1007/s10840-023-01468-1. Epub 2023 Jan 18.
PMID: 36652082RESULT
Related Links
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
February 23, 2021
Study Start
April 1, 2021
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
February 2, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share