ACC/AHA/NASPE Class 1, IIa or IIb Indications Clinical Trial
Official title:
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
| NCT number | NCT01117792 |
| Other study ID # | DN-01040 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2008 |
| Est. completion date | August 2009 |
| Verified date | July 2021 |
| Source | Boston Scientific Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | August 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Replacement of an existing implanted transvenous ICD system - Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system - Age is >= 18 years - Appropriate pre-operative ECG as measured with a specially developed template Exclusion Criteria: - Subjects unable or unwilling to provide informed consent - Any condition which precludes the subject's ability to comply with the study requirements - Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study - Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor. - Patients with a serious medical condition and life expectancy of less than one year. - Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing - Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant - Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Policlinico San Donato | San Donato Milanese | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Universitair Medisch Centrum | Groningen | |
| Netherlands | St. Antonius Ziekenhuis | Nieuwegein | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| New Zealand | Auckland City Hospital | Auckland | |
| New Zealand | Christchurch Hospital | Christchurch | |
| United Kingdom | Russells Hall Hospital | Dudley |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
Italy, Netherlands, New Zealand, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Conversion of Induced Ventricular Fibrillation | The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation. | Testing done during the implant procedure |