Trials / Completed
CompletedNCT00853645
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Subcutaneous Implantable Defibrillator (S-ICD) System |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2009-03-02
- Last updated
- 2021-07-06
- Results posted
- 2021-06-29
Locations
2 sites across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT00853645. Inclusion in this directory is not an endorsement.