9 results
The primary objective of this clinical Research is: • The objective of the study is to investigate concept and feasibility of view automation for SHD interventions. The study will explore the contribution of (semi) automatic views based procedural…
Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low…
The aim of this study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with an outpatient biopsy for histological confirmation, is a faster, safer, cheaper and therefore more cost-effective way to detect or…
To compare the clinical and angiographic outcomes of a strategy of native vessel PCI with SVG PCI in patients with prior CABG presenting with SVG failure and a clinical indication for repeat revascularization, as determined by the local Heart Team.
To assess the effect of adding a tapering decision aid on a dynamic flare prediction model to disease-activity-guided dose optimisation (DGDO) on the incidence of flares and medication use.
Evaluate the safety and efficacy of Medtronic Intrepid* TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of…
An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
To evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with IPF.
The primary objective and hypothesis is to assess whether the SP-GRIPFLOW Catheter is safe and performs as intended. The primary hypothesis is that blood flow through the catheters and cerebral perfusion during open surgical repair of the distal…
The primary objective of this feasibility study is to demonstrate the initial safety and effectiveness of the CellFX® nsPFA* Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more…