The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)

Sudden Cardiac Death Clinical Trial

— iSuSI  

Official title:

The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390047
• Other study ID #: ISuSI 1.0
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2022
• Source: University of Luebeck
• Contact: Julia Vogler, Dr.
• Phone: +49 451 500
• Email: Julia.vogler[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: September 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Locations

Country	Name	City	State
Germany	Clinic for Rhythmology	Luebeck	Schleswig Holstein

Sponsors (4)

Lead Sponsor	Collaborator
University of Luebeck	Giovanni Forleo, M.D., Mauro Biffi, M.D., Prof. Jürgen Kuschyk, M.D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall complication rate	combination of device related complications and inappropriate shocks	through study completion, an average of 2 years
Primary	Rate of appropriate shocks	Appropriate therapies delivered by the devices	through study completion, an average of 2 years
Primary	Rate of inappropriate shocks	Inappropriate therapies delivered by the devices	through study completion, an average of 2 years
Secondary	Device-related complication rate	Rate of complications pertaining to the device	immediately after the intervention/procedure/surgery"
Secondary	DFT impact	Impact of defibrillator function test (DFT) on long term arrhythmia outcome or mortality	2 year
Secondary	Rate of replacements	Generator replacements	2 year
Secondary	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
Secondary	Rate of device upgrades	need for device upgrade due to pacing needs	through study completion, an average of 2 year