Clinical trial NCT05390047: The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)
Official title: The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Cardiac Death
Keywords: subcutaneous implantable cardioverter defibrillator
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Prof. Jürgen Kuschyk, M.D
name: Giovanni Forleo, M.D.
name: Mauro Biffi, M.D.
First posted: 2022-05-25
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in whom a S-ICD was implanted for primary or secondary prevention

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.

Detailed description: The S-ICD has a CE mark and is FDA approved since 2012 and is mentioned as a potential therapy strategy in the current AHA guidelines on the management of patients with ventricular arrhythmias.2 However, although implant-related complications seem to be reduced by the S-ICD in randomized controlled trials, the rate of inappropriate shocks remains high in S-ICD patients (10-13%).3-5 The most common reason for inappropriate shocks is cardiac oversensing, mostly due to T-wave oversensing or low amplitude of the subcutaneous signal, which not commonly found in patients with transvenous ICDs. Data on the role of the Defibrillation Threshold Testing (DFT), the rate of infectious complications (lead or device complications), the use of the S-ICD in children and adolescents, and the outcome of patients with an S-ICD according to their underlying cardiac substrate are sparse. The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting with a special focus on perioperative complication rate, the role of DFT testing in S-ICD, the use of the S-ICD in cohorts that are underrepresented in clinical studies (adolescents and geriatrics), the outcome and risk factors of ineffective, inappropriate and appropriate shocks and the differences in outcomes according to the underlying cardiac disease.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

- none

Primary outcomes:
measure: Overall complication rate
timeFrame: through study completion, an average of 2 years
measure: Rate of appropriate shocks
timeFrame: through study completion, an average of 2 years
measure: Rate of inappropriate shocks
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Device-related complication rate
timeFrame: immediately after the intervention/procedure/surgery"
measure: DFT impact
timeFrame: 2 year
measure: Rate of replacements
timeFrame: 2 year
measure: Role of Gender in primary outcomes
timeFrame: through study completion, an average of 2 year
measure: Rate of device upgrades
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Clinic for Rhythmology
state: Schleswig Holstein
Study officials:
References: