Trials / Completed
CompletedNCT01000532
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 88 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SIELLO JT/T | Implantation of SIELLO and BPPU pacemaker leads |
| DEVICE | Pacemaker therapy | Pacemaker therapy |
| DEVICE | BPPU JT/T | Implantation of SIELLO and BPPU pacemaker leads |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2010-09-01
- Completion
- 2011-02-01
- First posted
- 2009-10-23
- Last updated
- 2011-11-16
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT01000532. Inclusion in this directory is not an endorsement.