MENA TAVI is a single arm, prospective, open label and multicenter registry. The objective is to evaluate the ACURATE NEO 2 in the Middle East population suffering from severe symptomatic aortic stenosis. The objective is to enroll 100 patients from 6 investigational sites and patients will be...
START YOUNG is a groundbreaking, investigator-initiated, prospective, multicenter, randomized trial comparing surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) using the balloon-expandable Myval THV in patients aged 65 to 75 years with symptomatic severe...
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II – Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients
Aprospective, single-arm, multi-center, observational, post-market clinical follow-up study, aimed to assess the safety and effectiveness/performance of the self-expanding VitaFlow Liberty™ Transcatheter Aortic Valve System in symptomatic patients with severe aortic stenosis in the post market use...
TACTIC is a prospective, multi-center, randomized 1:1, controlled, open label, study. The objective of the study is to evaluate the impact of sustained thrombectomy versus no thrombectomy during primary percutaneous coronary intervention (PPCI) on microvascular obstruction and infarct size, as...
GLYCAR STUDY is a Post Market Multicenter clinical investigation of GLYCAR Bovine pericardial patch with EnCap™ Technology in cardiac and vascular repair or reconstruction surgery. The main objective of this study is to collect real-world, long term clinical data in 100 adult and pediatric patients...
An international, multicenter, prospective, randomized clinical investigation to evaluate the safety and effectiveness of the Conformal CLAAS System for left atrial appendage occlusion, in comparison to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in...
Cardiovalve proposes a non-invasive, simply deployed, transferal expandable bioprosthetic valve for eliminating tricuspid regurgitation in patients who are not suitable for open heart surgery. Cardiovalve targets an unmet clinical need. TARGET study is a prospective, single arm, open label, multi...
Prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. 150 subjects will be enrolled in up to 20 sites in multiple countries/regions including...
The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, in the context of an observational investigator-initiated trial (IIT). There are no additional and/or...
