clinical trial · NCT05478161
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
NVT GmbH·N/A·completed·n = 137
Transcatheter Aortic Valve Implantation(ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
brief summary
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System. The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 107 patients need to be enrolled in the study.
started
Jan 24, 2023
primary completion
Dec 20, 2023
completion
Dec 17, 2024
last updated
Feb 24, 2026
official title
Investigation of the Safety and Performance of the NVT ALLEGRA THV System With a New Delivery System in Patients With Severe Calcified Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol