TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis

Launched by SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO., LTD. · Sep 13, 2024

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ClinConnect Summary

The TAVR vs. SAVR Study is looking at a new treatment option called the VitaFlow Liberty® for patients with severe bicuspid aortic valve stenosis, a condition where the heart's aortic valve does not open properly, making it hard for blood to flow. This trial will help researchers understand how safe and effective this new valve delivery system is compared to traditional surgery. The study is not yet recruiting participants, but it aims to include adults aged 65 to 75 years who have symptoms of severe aortic stenosis, such as shortness of breath or chest pain, and who are considered to have a low or intermediate risk for surgery.

To join the trial, participants must meet certain criteria, including having a specific level of heart valve narrowing confirmed by an ultrasound of the heart. They should also be able to tolerate certain medications that prevent blood clots. However, some individuals will not be eligible, such as those with recent heart attacks, certain severe health conditions, or previous valve surgeries. If you qualify and choose to participate, you can expect close monitoring during the trial to ensure your safety and health. This study could potentially help improve treatment options for people with aortic stenosis.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject aged ≤ 75 years;
• • 2. With symptomatic severe bicuspid aortic stenosis, defined as: peak flow velocity ≥ 4.0m/s, or mean trans-aortic pressure gradient ≥ 40mmHg, or aortic orifice area (AVA) ≤ 1.0cm2 (or AVA index ≤ 0.6cm2/m2) confirmed by echocardiography；
• • 3. New York Heart Association (NYHA) cardiac function classification ≥ Class II;
• • 4. With an intermediate or low risk of surgical procedures (STS score ≤8%) assessed by the local heart team;
• • 5. Voluntarily participate in this study and sign the informed consent form.
• Exclusion Criteria:
• • 1. Known allergy or resistance to study device and control device components such as nitinol or contrast media;
• • 2. Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
• • 3. Known presence of active infective endocarditis or other active infection;
• • 4. Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
• • 5. Ascending aorta width ≥50mm;
• • 6. Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place;
• • 7. The aortic root anatomy not suitable for transcatheter aortic valve implantation confirmed by preoperative imaging (including aortic root calcification that influence the sufficient dilatation of the rposthetic valve);
• • 8. Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;
• • 9. Acute myocardial infarction (defined as Q-wave MI or non-Q-wave MI) within 30 days prior to surgery;
• • 10. Invasive therapeutic cardiac surgery within 30 days prior to surgery (except for temporary pacemaker or implantable cardioverter-defibrillator implantation);
• • 11. Clinically diagnosed stroke or TIA within 3 months prior to surgery;
• • 12. Gastrointestinal bleeding requiring hospitalization or transfusion therapy or other clinically significant bleeding or coagulation disorders within 3 months prior to surgery, which preclude the required antiplatelet therapy in the study;
• • 13. Comorbid with severe native coronary artery lesions that require revascularization therapy;
• • 14. Comorbid with severe mitral or tricuspid regurgitation;
• • 15. Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance;
• • 16. Comorbid with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF \<20%);
• • 17. Comorbid with end-stage renal diseases requiring chronic dialysis;
• • 18. Comorbid with blood dyscrasias defined as leukopenia (white blood cell count \< 3×109/L), thrombocytopenia (platelet count \< 50×109/L), history of bleeding diathesis or coagulopathy, or hypercoagulable states;
• • 19. Subjects corresponding to the criteria of a vulnerable population (including patients who are unable to fully understand all aspects of the study, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment);
• • 20. Female subjects known to be pregnant or lactating;
• • 21. Life expectancy is less than 12 months as assessed by the investigator;
• • 22. Subject is participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively;
• • 23. Any other condition that, at the discretion of investigator or heart team, may preclude the subject's safe participation in the study.