The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI) (iSuSI)
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| ClinicalTrials.gov Identifier: NCT05390047 |
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Recruitment Status :
Recruiting
First Posted : May 25, 2022
Last Update Posted : June 1, 2022
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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
| Tracking Information | |||||||||
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| First Submitted Date | February 22, 2022 | ||||||||
| First Posted Date | May 25, 2022 | ||||||||
| Last Update Posted Date | June 1, 2022 | ||||||||
| Estimated Study Start Date | June 1, 2022 | ||||||||
| Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI) | ||||||||
| Official Title | The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi) | ||||||||
| 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. |
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| 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 | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients in whom a S-ICD was implanted for primary or secondary prevention | ||||||||
| Condition | Sudden Cardiac Death | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
4000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 30, 2024 | ||||||||
| Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: - none |
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05390047 | ||||||||
| Other Study ID Numbers | ISuSI 1.0 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Prof. Roland Richard Tilz, University of Luebeck | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | University of Luebeck | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators |
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| Investigators | Not Provided | ||||||||
| PRS Account | University of Luebeck | ||||||||
| Verification Date | May 2022 | ||||||||