Aortic Valve Stenosis
Conditions
Brief 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.
Interventions
DEVICELeaflex™ Performer
A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
Sponsors
Pi-cardia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study includes two stages: * Exploratory stage - an exploratory examination of patients with an aim to streamline the study procedures, to reach a safe and consistent result, to evaluate the target patient population and adapt scoring protocol to optimize efficacy of the Leaflex™ procedure. The protocol does not include a formal staticstical analysis of the results of subjects enrolled in this stage. * Confirmatory - confirmatory analysis with an aim to demonstrate the Leaflex™ safety and performance.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with symptomatic, severe aortic stenosis who are 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in aortic valve area | Baseline to 3 days | assessed by echo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of worsening of aortic regurgitation | Baseline to 30 days | by greater than 1 grade |
| Rate of device related adverse events | 12 months | — |
| Change in 6 minute walk test | 1, 6 and 12 months | distance (meters) |
| Rate of all-cause mortality and all-cause stroke (VARC 2) | 30 days post procedure | Composite |
| Change in aortic valve area | 30 days, 3, 6, 9 and 12 months | assessed by echo |
| Change in pressure gradients | 30 days, 3, 6, 9 and 12 months | assessed by echo |
| Quality of Life Improvement | 1, 6 and 12 months | KCCQ |
Countries
Hungary
Outcome results
None listed