The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)
ConditionSudden Cardiac Death
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Luebeck
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
Patients in whom a S-ICD was implanted for primary or secondary prevention
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall complication rate
combination of device related complications and inappropriate shocks
Time frame
through study completion, an average of 2 years2
Rate of appropriate shocks
Appropriate therapies delivered by the devices
Time frame
through study completion, an average of 2 years3
Rate of inappropriate shocks
Inappropriate therapies delivered by the devices
Time frame
through study completion, an average of 2 yearsSecondary outcomes
1
Device-related complication rate
Rate of complications pertaining to the device
Time frame
immediately after the intervention/procedure/surgery"2
DFT impact
Impact of defibrillator function test (DFT) on long term arrhythmia outcome or mortality
Time frame
2 year3
Rate of replacements
Generator replacements
Time frame
2 year4
Role of Gender in primary outcomes
Analysis of the potential role of gender on the primary outcomes
Time frame
through study completion, an average of 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Luebeck
Lead sponsor
Prof. Jürgen Kuschyk, M.D
Collaborator
Giovanni Forleo, M.D.
Collaborator
Mauro Biffi, M.D.
Collaborator
Source ClinicalTrials.gov