Trials / Completed
CompletedNCT04952909
The ShortCut™ Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Pi-cardia · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ShortCut™ | Splitting bioprosthetic aortic valve leaflets |
Timeline
- Start date
- 2022-01-21
- Primary completion
- 2023-09-30
- Completion
- 2023-12-31
- First posted
- 2021-07-07
- Last updated
- 2025-02-03
- Results posted
- 2025-02-03
Locations
23 sites across 5 countries: United States, France, Germany, Israel, United Kingdom
Source: ClinicalTrials.gov record NCT04952909. Inclusion in this directory is not an endorsement.