The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)
iSuSI
The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)
1 other identifier
observational
4,000
1 country
1
Brief Summary
The entirely subcutaneous implantable defibrillator (S-ICD) (Emblem, Boston Scientific, Marlborough, MA, USA) was introduced as a new therapeutic alternative to the conventional transvenous ICD in 2009 and implantations are rapidly expanding since then.1 Implantation of the S-ICD seems to reduce implant-related perioperative complications such as pneumothorax, hematoma and cardiac tamponade. The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJuly 1, 2024
June 1, 2024
2.9 years
February 22, 2022
June 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall complication rate
combination of device related complications and inappropriate shocks
through study completion, an average of 2 years
Rate of appropriate shocks
Appropriate therapies delivered by the devices
through study completion, an average of 2 years
Rate of inappropriate shocks
Inappropriate therapies delivered by the devices
through study completion, an average of 2 years
Secondary Outcomes (5)
Device-related complication rate
immediately after the intervention/procedure/surgery"
DFT impact
2 year
Rate of replacements
2 year
Role of Gender in primary outcomes
through study completion, an average of 2 year
Rate of device upgrades
through study completion, an average of 2 year
Eligibility Criteria
Patients in whom a S-ICD was implanted for primary or secondary prevention
You may qualify if:
- Implantation of an S-ICD, regardless of the technique
- At least 1 month of follow up
- At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center (e.g. in person visit or remote follow up)
You may not qualify if:
- \- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Luebecklead
- Prof. Jürgen Kuschyk, M.Dcollaborator
- Giovanni Forleo, M.D.collaborator
- Mauro Biffi, M.D.collaborator
Study Sites (1)
Clinic for Rhythmology
Lübeck, Schleswig-Holstein, 23538, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Roland Richard Tilz
Study Record Dates
First Submitted
February 22, 2022
First Posted
May 25, 2022
Study Start
July 1, 2022
Primary Completion
June 1, 2025
Study Completion
September 30, 2025
Last Updated
July 1, 2024
Record last verified: 2024-06