Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

Launched by NVT GMBH · Mar 27, 2023

Keywords

ClinConnect Summary

The EMPIRE II study is investigating a new heart valve system called the ALLEGRA Plus THV System to see how safe and effective it is for patients with severe aortic stenosis (a narrowing of the heart’s aortic valve) or those with failing surgical heart valves. The main goal of the study is to track the rates of death or stroke within the first year and to evaluate how well the device works within the first week after the procedure. The researchers aim to enroll 177 patients, and they are currently looking for participants aged 18 and older who meet specific health criteria.

To be eligible, participants should have severe aortic valve problems that cause symptoms, and their condition must be approved by a specialized heart team. However, certain medical conditions, such as severe heart dysfunction, recent heart attacks, or significant issues with blood vessels, may prevent someone from joining the study. If you choose to participate, you will need to sign an informed consent form and attend follow-up visits to monitor your health after the procedure. This study could help improve treatment options for patients with serious heart valve issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2), AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography OR symptomatic patients with degeneration of a surgical bioprosthetic valve (stenosis +/- insufficiency) on site-reported echocardiography
• • 2. Local multi-disciplinary Heart Team and Central Screening Committee (CSC) agree on indication and eligibility for TAVI
• • 3. Age ≥18 years
• • 4. Patient has signed the Patient Informed Consent Form
• • 5. Patient is willing and able to comply with requirements of the study, including all follow-up visits
• Exclusion Criteria:
• Patient will not be included if ANY one of the following conditions exists:
• General:
• • 1. Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is \<16.5 mm or \>27 mm
• • 2. Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported)
• • 3. Significant disease of the aorta that would preclude safe advancement of the ALLEGRA Plus THV System
• • 4. Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible
• • 5. Porcelain aorta
• • 6. Severe left ventricular dysfunction with ejection fraction (EF) \<20% (site-reported)
• • 7. Evidence of active endocarditis or other acute infections
• • 8. Renal failure requiring continuous renal replacement therapy
• • 9. Untreated clinically significant coronary artery disease requiring revascularization
• • 10. Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure
• • 11. Acute MI ≤30 days prior to the index procedure
• • 12. Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
• • 13. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score \>2)
• • 14. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets \<80,000/µl), acute anemia (hemoglobin \<10 g/dl), leukopenia (WBC \<3000/ µl)
• • 15. Active peptic ulcer or gastrointestinal (GI) bleeding ≤3 months
• • 16. Severe (greater than 3+) mitral insufficiency (site-reported)
• • 17. Uncontrolled atrial fibrillation
• • 18. Required emergency surgery for any reason
• • 19. Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
• • 20. Life expectancy ≤12 months due to other medical illness
• • 21. Currently participating in another investigational drug or device study
• • 22. Hypertrophic obstructive cardiomyopathy
• • 23. Pregnancy or intend to become pregnant during study participation
• Specific exclusions in patients with native aortic valve disease (site-reported):
• • 24. Unicuspid or bicuspid aortic valve
• • 25. Non-calcified aortic stenosis
• • 26. Identified risk of coronary occlusion due to Sinus of Valsalva anatomy and/or bulky calcified aortic valve leaflets in close proximity to coronary ostia
• Specific exclusions in patients with degenerated surgical bioprosthetic aortic valves (valve-in-valve) (site-reported):
• • 27. High risk of coronary occlusion
• • 28. Partially detached leaflets that may obstruct a coronary ostium