The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI) (iSuSI)

The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)

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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Death

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Julia Vogler, Dr.; Phone Number: 44639 +49 451 500; Email: Julia.vogler@uksh.de
• Study Contact Backup: Name: Cornelia Wolf; Phone Number: 44540 +49451500; Email: cornelia.wolf@uksh.de

Study Locations

• Germany
  • Schleswig Holstein
    • Luebeck, Schleswig Holstein, Germany, 23538
      • Recruiting
      • Clinic for Rhythmology
      • Contact: Julia S Vogler, Dr.med.; Phone Number: 44639 +49451500; Email: julia.vogler@uksh.de
      • Contact: Mirco Kuechler; Phone Number: 77075 +49451500; Email: mirco.kuechler@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients in whom a S-ICD was implanted for primary or secondary prevention

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related complication rate	Rate of complications pertaining to the device	immediately after the intervention/procedure/surgery"
DFT impact	Impact of defibrillator function test (DFT) on long term arrhythmia outcome or mortality	2 year
Rate of replacements	Generator replacements	2 year
Role of Gender in primary outcomes	Analysis of the potential role of gender on the primary outcomes	through study completion, an average of 2 year
Rate of device upgrades	need for device upgrade due to pacing needs	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: University of Luebeck
• Collaborators: Prof. Jürgen Kuschyk, M.D; Giovanni Forleo, M.D.; Mauro Biffi, M.D.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: subcutaneous implantable cardioverter defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: ISuSI 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No