Trials / Terminated
TerminatedNCT04649099
The Leaflex™ Standalone Study Protocol
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Pi-cardia · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis. Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Leaflex™ Performer | A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets. |
Timeline
- Start date
- 2020-09-02
- Primary completion
- 2023-11-20
- Completion
- 2024-08-14
- First posted
- 2020-12-02
- Last updated
- 2025-02-28
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT04649099. Inclusion in this directory is not an endorsement.