SAITO1B is prospective, single arm, First-In-Human study. The objective is to assess the feasibility and safety of the TaviPilot augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly, reduce implantation depth variations in patients...
The Aortoseal Endostapling System is intended to provide enhanced fixation between an endovascular graft and the native aorta and to provide enhanced apposition of the endovascular graft to the native aorta. It is indicated in patients undergoing, or having undergone, treatment of an abdominal...
A Prospective Randomized (1:1), Multi-center, International, Open label Clinical trial. The objective is to demonstrate non-inferiority for Target Vessel Failure (TVF) of a treatment strategy with first line SELUTION SLR Drug Eluting Balloon (DEB) plus provisional Drug Eluting Stent (DES) vs...
The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1...
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...
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...
The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast. ID: NCT02793661
Single-arm, Prospective, Open label, All Comers, Multicenter Registry. The objective is to collect and evaluate clinical data regarding the safety and performance of the Support C in a real-world setting (in clinical routine)
The SYNC Study: Pivotal Clinical Study of VDI’s Ultra-High FrequencY Electrocardiogram (UHF-ECG) for the DiagNosis of VentriCular Electrical Dyssynchrony (VED) The VDI Ultra-High Frequency (UHF) ECG System is intended to aid in the detection of Ventricular Electrical Dyssynchrony (VED) in patients...
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...
