Trials / Terminated
TerminatedNCT05052684
The Leaflex™ Brazilian Standalone Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Pi-cardia · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
Detailed description
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of 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
- 2022-10-03
- Primary completion
- 2024-11-14
- Completion
- 2024-11-14
- First posted
- 2021-09-22
- Last updated
- 2025-11-20
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05052684. Inclusion in this directory is not an endorsement.