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

• ClinicalTrials.gov Identifier: NCT05390047
• Recruitment Status: Recruiting
• First Posted: May 25, 2022
• Last Update Posted: June 1, 2022
• Sponsor: University of Luebeck
• Collaborators: Prof. Jürgen Kuschyk, M.D; Giovanni Forleo, M.D.; Mauro Biffi, M.D.
• Information provided by (Responsible Party): Prof. Roland Richard Tilz, University of Luebeck

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)
• Estimated Study Start Date: June 1, 2022
• Estimated Primary Completion Date: June 1, 2024
• Estimated Study Completion Date: September 30, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Overall complication rate [ Time Frame: through study completion, an average of 2 years ]
   combination of device related complications and inappropriate shocks
2. Rate of appropriate shocks [ Time Frame: through study completion, an average of 2 years ]
   Appropriate therapies delivered by the devices
3. Rate of inappropriate shocks [ Time Frame: through study completion, an average of 2 years ]
   Inappropriate therapies delivered by the devices

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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

Contacts and Locations

Contacts

Contact: Julia Vogler, Dr.; +49 451 500 ext 44639; Julia.vogler@uksh.de

Contact: Cornelia Wolf; +49451500 ext 44540; cornelia.wolf@uksh.de

Locations

Germany

Clinic for Rhythmology; Recruiting

Luebeck, Schleswig Holstein, Germany, 23538

Contact: Julia S Vogler, Dr.med. +49451500 ext 44639 julia.vogler@uksh.de

Contact: Cornelia Wolf +49451500 ext 44672 Cornelia.Wolf@uksh.de

Sponsors and Collaborators

University of Luebeck

Prof. Jürgen Kuschyk, M.D

Giovanni Forleo, M.D.

Mauro Biffi, M.D.

More Information

• Responsible Party: Prof. Roland Richard Tilz, Prof. Dr. med. Roland Richard Tilz, University of Luebeck
• ClinicalTrials.gov Identifier: NCT05390047
• Other Study ID Numbers: ISuSI 1.0
• First Posted: May 25, 2022
• Last Update Posted: June 1, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Roland Richard Tilz, University of Luebeck:

subcutaneous implantable cardioverter defibrillator

Additional relevant MeSH terms:

Death, Sudden, Cardiac; Death; Pathologic Processes; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden