Aortic Stenosis narrowing of the aortic valve
Conditions
Interventions
all patients undergo a trans-femoral catheter treatment of the aortic heart
valve.
Sponsors
Pi-Cardia Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male and female age >18 years. 2. Patient with severe aortic stenosis. 3. Senile degenerative severe aortic valve stenosis with echocardiography derived criteria: mean gradient > 40 mmHg OR jet velocity > 4.0 m/s OR AVA * 1.0 cm2 OR AVA index (AVAi) * 0.6 cm2/m2. 4. NYHA Functional Class * 2 OR exercise test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia. 5. Not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.
Exclusion criteria
Exclusion criteria: 1. Aortic valve is unicuspid, bicuspid, or non-calcified. 2. Severe aortic regurgitation (>2+). 3. An exceptional aortic valve leaflet Calcium morphology, as determined by the CT Core Lab. 4. Pre-existing mechanical or bioprosthetic aortic or mitral valve. 5. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 6. Coronary disease that, in the opinion of the heart team, should be treated; or treatment of coronary disease * 1 month prior to index procedure. 7. Aortic balloon valvuloplasty * 3 months prior to index procedure. 8. CVA or TIA * 12 months prior to index procedure. 9. History of a myocardial infarction (MI) * 6 weeks prior to index procedure. 10. Previous or current bacterial endocarditis. 11. Ongoing severe infection or sepsis. 12. Life expectancy * 12 months post index procedure due to morbidity other than aortic valve related.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary performance endpoint - change in AVA measured by echocardiography before treatment with the Leaflex* (within 7 days prior to index procedure) and after treatment with the Leaflex* (within 3 days post index procedure). Main safety endpoints: * Composite rates of all-cause mortality and stroke (according to VARC-2 definitions48) through 30 days post the procedure. * Worsening of aortic regurgitation (AR) by >1 grade assessed by echocardiography at 30 days post the procedure compared to before treatment with the Leaflex* (within 7 days prior to treatment) and to after treatment with the Leaflex* (within three days post treatment). * Assessment of all adverse events from enrollment up to 12 months post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance endpoints: * Post Leaflex* AVA, AVAi and peak and mean pressure gradients measured by echocardiography after treatment with the Leaflex* (within 3 days post index procedure). * Intra-procedural change of invasive transvalvular pressure gradients, computed as difference in mean and in peak-to-peak pressure gradients across the aortic valve immediately prior to treatment with the Leaflex* and immediately following treatment with the Leaflex*. * Change in AVA and in peak and mean pressure gradients, measured by echocardiography, from before treatment with the Leaflex* (within 7 days prior to index procedure) and from after treatment with the Leaflex* (within 3 days post index procedure) to 1, 3, 6, 9 and 12 months post procedure. * Change in 6MWT from baseline to 1, 6 and 12 months post procedure. * Change in quality of life from baseline to 1, 6 and 12 months post procedure. Note: AVA and AVAi shall be computed by echocardiography as Effective Orifice Area (EOA) and Effective Orifice Area Index (EOAi). | — |
Countries
Netherlands
Outcome results
None listed