Sudden Cardiac DeathiSuSINCT05390047
The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)
An observational study of Sudden Cardiac Death, run by University of Luebeck at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 4,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in whom a S-ICD was implanted for primary or secondary prevention
Who may be able to join
- 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)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic for Rhythmology
Lübeck, Schleswig-Holstein, 23538
Julia S Vogler, Dr.med., +49451500 ext. 44639, julia.vogler@uksh.de
Mirco Kuechler, +49451500 ext. 77075, mirco.kuechler@uksh.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Sudden Cardiac Death
- Keywords
- subcutaneous implantable cardioverter defibrillator
- Medical subject headings
- Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complication rate
combination of device related complications and inappropriate shocks
Measured: through study completion, an average of 2 years
Rate of appropriate shocks
Appropriate therapies delivered by the devices
Measured: through study completion, an average of 2 years
Rate of inappropriate shocks
Inappropriate therapies delivered by the devices
Measured: through study completion, an average of 2 years
Secondary outcomes (5)
Device-related complication rate
Rate of complications pertaining to the device
Measured: immediately after the intervention/procedure/surgery"
DFT impact
Impact of defibrillator function test (DFT) on long term arrhythmia outcome or mortality
Measured: 2 year
Rate of replacements
Generator replacements
Measured: 2 year
Role of Gender in primary outcomes
Analysis of the potential role of gender on the primary outcomes
Measured: through study completion, an average of 2 year
Rate of device upgrades
need for device upgrade due to pacing needs
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jul 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Jürgen Kuschyk, M.D, Giovanni Forleo, M.D., Mauro Biffi, M.D.
- Responsible party
- Principal investigator, Prof. Roland Richard Tilz, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390047
- Sponsor's protocol ID
- ISuSI 1.0
- Acronym
- iSuSI
- Status last verified
- Jun 2024
- First submitted
- 22 Feb 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)
- ClinicalTrials.gov ID
- NCT05390047
- Acronym / sponsor ID
- iSuSI / ISuSI 1.0
- Conditions
- Sudden Cardiac Death
- Keywords
- subcutaneous implantable cardioverter defibrillator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Prof. Jürgen Kuschyk, M.D, Giovanni Forleo, M.D., Mauro Biffi, M.D.
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in whom a S-ICD was implanted for primary or secondary prevention
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall complication rate
Time frame: through study completion, an average of 2 years
combination of device related complications and inappropriate shocks
Rate of appropriate shocks
Time frame: through study completion, an average of 2 years
Appropriate therapies delivered by the devices
Rate of inappropriate shocks
Time frame: through study completion, an average of 2 years
Inappropriate therapies delivered by the devices
5 secondary outcomes
Device-related complication rate
Time frame: immediately after the intervention/procedure/surgery"
DFT impact
Time frame: 2 year
Rate of replacements
Time frame: 2 year
Role of Gender in primary outcomes
Time frame: through study completion, an average of 2 year
Rate of device upgrades
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Vogler, Dr. (+49 451 500 ext. 44639, Julia.vogler@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complication rate (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.