Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
Megadott ok: Interim analysis showed ALLEGRA Plus did not provide clinically meaningful benefit over the CE-marked ALLEGRA THV System. Sponsor discontinued ALLEGRA Plus as a standalone product. Not terminated for safety reasons.
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
5 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálat adatai
- Ki végzi
- NVT GmbH
- Azonosító
- NCT05804903
- A regiszteradat frissítve
- 2026. március 9.
- Eredeti leírás
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System.A teljes eredeti leírásKevesebb
InvEstigation of the Safety and Performance of the NVT ALLEGRA Plus THV SysteM in Patients With Severe aortIc Stenosis or Failed suRgical Aortic bioprosthEsis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System.
The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months. And the primary performance endpoint is device success at 7 days.
Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 177 patients need to be enrolled in the study.
Bevonási feltételek: 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; Local multi-disciplinary Heart Team and Central Screening Committee (CSC) agree on indication and eligibility for TAVI; Age ≥18 years; Patient has signed the Patient Informed Consent Form; Patient is willing and able to comply with requirements of the study, including all follow-up visits.
Kizáró feltételek: Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure; Acute MI ≤30 days prior to the index procedure; 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); Required emergency surgery for any reason; Currently participating in another investigational drug or device study; 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):; Patient will not be included if ANY one of the following conditions exists:; Significant disease of the aorta that would preclude safe advancement of the ALLEGRA Plus THV System; Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible; Evidence of active endocarditis or other acute infections; Renal failure requiring continuous renal replacement therapy; Untreated clinically significant coronary artery disease requiring revascularization; Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days; Active peptic ulcer or gastrointestinal (GI) bleeding ≤3 months; Severe (greater than 3+) mitral insufficiency (site-reported); Life expectancy ≤12 months due to other medical illness; Pregnancy or intend to become pregnant during study participation; Specific exclusions in patients with native aortic valve disease (site-reported):; Severe left ventricular dysfunction with ejection fraction (EF) <20% (site-reported); 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); 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; General:; Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16.5 mm or >27 mm; Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported); Porcelain aorta; Uncontrolled atrial fibrillation; Hypertrophic obstructive cardiomyopathy; Unicuspid or bicuspid aortic valve; Non-calcified aortic stenosis; High risk of coronary occlusion; Partially detached leaflets that may obstruct a coronary ostium.