The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)

Last updated: June 28, 2024
Sponsor: University of Luebeck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Ischemia

Heart Defect

Heart Disease

Treatment

N/A

Clinical Study ID

NCT05390047
ISuSI 1.0
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 clinicalpractice of every center (e.g. in person visit or remote follow up)

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 4000
Study Start date:
July 01, 2022
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Clinic for Rhythmology

    Luebeck, Schleswig Holstein 23538
    Germany

    Active - Recruiting

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