Aortic stenosis
Conditions
Interventions
experimental group:Aortic valve repair with Leaflex Performer
Sponsors
Boao super hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged >= 18 years. 2. Patient with severe aortic stenosis. 3. Senile degenerative severe native aortic valve stenosis with echocardiography derived criteria: mean gradient > 40 mmHg OR jet velocity > 4.0 m/s OR AVA = 2 OR exercise test that demonstrates a limited exercise capacity or decreased BP response. 5. Operable but not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement (patient may be eligible for BAV). 6. Patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC. 7. Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Aortic valve is unicuspid, bicuspid, or non-calcified. 2. Inoperable for emergency open-heart surgery. 3. Moderate or greater aortic regurgitation. 4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 5. Coronary artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease 2.5 mg/dL) and/or renal replacement therapy. 20. Active peptic ulcer or active gastrointestinal bleeding <= 3 months prior to index procedure. 21. Inability to tolerate or condition precluding treatment with anti-anticoagulation therapy during the valve treatment, or antiplatelet therapy during follow-up. 22. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication. 23. Known allergy to Nitinol alloys, stainless steel, Polyamide 12, Polyether block amide, Polytetrafluoroethylene (PTFE, Teflon), Polyphenylsulfone (PPSU), Polyvinyl chloride (PVC, DEHP Free), Polypropylene (PP), SurModics Serene coating (PhotoLink? surface modification), Silicone, Epoxy adhesive, Acrylic glue. 24. Known pregnancy or patient plans to become pregnant in next 12 months. 25. Life expectancy <= 12 months post index procedure not due to aortic valve related morbidity. 26. Need for emergency surgery for any reason. 27. Patient is too frail to withstand the index procedure, as determined by the Investigator. 28. Other medical, social or psychological conditions which, in the opinion of the Investigator or any of his team, preclude the patient from study participation. 29. Patient is currently participating in an investigational drug or another device study unless the drug/device is commercially available. CT Core Lab Exclusion Criteria 30. An excessive aortic valve leaflet Calcium morphology, such as diffused massive calcification with calcification depth of at least 4.5X4.5mm2, as determined by CT core lab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility and safety of the Leafle procedure;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); | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite rates of all-cause mortality and all-cause stroke through 30 days post the procedure;All-cause mortality rate;All-cause stroke rate;Ischemic stroke rate;Worsening of aortic regurgitation (AR) by >1 grade or any new AR greater than trace 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);All adverse events from enrollment up to 12 months post procedure (inclusive of minor and major access site related complications);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, 6 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; | — |
Countries
China
Contacts
Public ContactWu Yongjian, Fang Pihua
Outcome results
None listed