Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
This study has been completed.
Sponsor:
Cameron Health, Inc.
Information provided by:
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT01117792
First received: April 28, 2010
Last updated: May 4, 2010
Last verified: May 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
ACC/AHA/NASPE Class 1, IIa or IIb Indications |
Device: subcutaneous implantable defibrillator (S-ICD) system |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation |
Resource links provided by NLM:
Further study details as provided by Cameron Health, Inc.:
Primary Outcome Measures:
- Conversion of induced ventricular fibrillation [ Time Frame: testing done during the implant procedure ] [ Designated as safety issue: Yes ]Data was reported at 30 days and 6 months
| Enrollment: | 55 |
| Study Start Date: | December 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: S-ICD System |
Device: subcutaneous implantable defibrillator (S-ICD) system
implantable defibrillator system
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117792
Locations
| Italy | |
| Policlinico San Donato | |
| San Donato Milanese, Italy, 20097 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1100 DD | |
| Universitair Medisch Centrum | |
| Groningen, Netherlands, 9713 GZ | |
| St. Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435 CM | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3015 GD | |
| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1001 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8002 | |
| United Kingdom | |
| Russells Hall Hospital | |
| Dudley, United Kingdom, DY1 2HQ | |
Sponsors and Collaborators
Cameron Health, Inc.
Investigators
| Study Director: | Stephen O'Connor, PhD, Hon FRCP | Cameron Health, Inc. |
More Information
No publications provided
| Responsible Party: | Stephen A. O'Connor, Ph.D., Hon FRCP, Cameron Health, Inc. |
| ClinicalTrials.gov Identifier: | NCT01117792 History of Changes |
| Other Study ID Numbers: | DN-01040 |
| Study First Received: | April 28, 2010 |
| Last Updated: | May 4, 2010 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: Ministry of Health New Zealand: Medsafe |
ClinicalTrials.gov processed this record on May 21, 2013