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NCT01791127 · ClinicalTrials.gov registry record
Safety and Performance Study of the Siello S Pacing Lead
A clinical trial, sponsored by Biotronik.
- Terminated
- Registry status
- 1,758
- Enrollment target
NCT01791127: Clinical Trial study, sponsored by Biotronik.
NCT01791127 is a clinical trial that was terminated before completion, run by Biotronik. The registered enrollment target is 1,758 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791127 was terminated before completion, sponsored by Biotronik.
- TERMINATED
- Registry status
- 1,758 participants
- Enrollment target
Study Summary
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
Primary Outcome
The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Interventions
- DEVICE market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,758 participants |
| Start Date | 2013-03-13 |
| Est. Completion | 2019-04-17 |
Why NCT01791127 stopped before completion
NCT01791127 is an observational study that tracks outcomes without assigning an intervention. Its 1,758 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which market-released BIOTRONIK pacemaker system including one or two Siello S leads. is the first listed.
NCT01791127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01791127 about?
NCT01791127 is a clinical study titled "Safety and Performance Study of the Siello S Pacing Lead". The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
What is the current status of trial NCT01791127?
This trial is currently terminated. The enrollment target is 1,758 participants. The study started on 2013-03-13. Estimated completion is 2019-04-17.
What interventions are being tested in trial NCT01791127?
The interventions under investigation include: market-released BIOTRONIK pacemaker system including one or two Siello S leads. (DEVICE).
Who is sponsoring clinical trial NCT01791127?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
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