Trials / Withdrawn
WithdrawnNCT04636073
The Leaflex™ Early Feasibility Study
A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex™ Performer
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pi-cardia · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
Detailed description
A prospective, multicenter, single-arm, early feasibility 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
- 2024-06-01
- Primary completion
- 2024-06-01
- Completion
- 2024-06-01
- First posted
- 2020-11-19
- Last updated
- 2025-10-27
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04636073. Inclusion in this directory is not an endorsement.