Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Faile… (NCT05804903) | Clinical Trial Compass
SuspendedNot Applicable
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
Stopped: 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.
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
✕. Significant disease of the aorta that would preclude safe advancement of the ALLEGRA Plus THV System