The Leaflex™ Early Feasibility Study
Purpose
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.
Condition
- Aortic Valve Stenosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient with symptomatic, severe aortic stenosis who are operable, but not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. - Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.
Exclusion Criteria
- Inoperable for emergency surgery. - Moderate or greater aortic regurgitation. - Anatomic contraindications. - Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. - Aortic balloon valvuloplasty ≤ 3 months prior to index procedure. - Stroke ≤ 12 months prior to index procedure. - History of a myocardial infarction ≤ 6 weeks prior to index procedure. - Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. - Hemodynamic instability. - Hypertrophic cardiomyopathy with obstruction. - Left ventricle ejection fraction <30%. - Ongoing severe infection, including endocarditis, or sepsis. - Life expectancy ≤ 12 months.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Leaflex™ Performer |
|
More Details
- NCT ID
- NCT04636073
- Status
- Withdrawn
- Sponsor
- Pi-cardia