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NCT01115907 · ClinicalTrials.gov registry record · Phase 3
Freedom SOLO Stentless Heart Valve Study
A Phase 3 study, sponsored by Sorin Group USA.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
NCT01115907: Completed Phase 3 study, sponsored by Sorin Group USA.
NCT01115907 is a Phase 3 study that has completed, run by Sorin Group USA. The registered enrollment target is 251 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01115907, a Phase 3 study, has completed, sponsored by Sorin Group USA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
Study Summary
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
Primary Outcome
The complication and survival rates for the SOLO valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported in the literature for other stentless bioprostheses and stented pericardial valves.
Interventions
- DEVICE Freedom SOLO Stentless Heart Valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01115907 record still lists
NCT01115907 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Freedom SOLO Stentless Heart Valve is the first listed.
NCT01115907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01115907 about?
NCT01115907 is a clinical study titled "Freedom SOLO Stentless Heart Valve Study". The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
What is the current status of trial NCT01115907?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2010-12. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01115907?
The interventions under investigation include: Freedom SOLO Stentless Heart Valve (DEVICE).
Who is sponsoring clinical trial NCT01115907?
This trial is sponsored by Sorin Group USA, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01115907's enrollment target sits among peer trials
251 1249th of 2000 higher than 752 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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