47 results
This study is designed to gather prospective data on a) the clinical effectiveness, b) the tissue structure changes, and c) the short term costs of ankle joint distraction (AJD) in 10 patients with HAA during 10 years follow-up.
Establishing efficacy and safety of the electrodes and implantable pulse generators (IPGs), which are used for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD).
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…
The purpose of this study is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft System versus Gore Excluder/Excluder Conformable AAA Endoprosthesis in subjects with AAA.
The purpose of the VISABL-VT clinical investigation is to demonstrate safety and efficacy of RF ablation of ventricular tachycardia (VT) attributable to ischemic cardiomyopathy (ICM) with the Vision-MR Ablation Catheter 2.0. Data collected from…
To assess the feasibility of a larger study comparing HFNO with NIV as first line treatment in hypercapnic, acidotic AECOPD.
The primary objective of this study is to generate reference values for NFMS parameters as well as for 2D-STE parameters during the second trimester, 16 until 28 weeks gestational age. The secondary objective is to investigate the diagnostic…
To understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions prior to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area (…
This traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…
The primary objective of this study is to investigate if the use of Heli-FX EndoAnchors in conjunction with placement of aortic stent grafts under instructions foruse (IFU) conditions in aneurysms with a wide neck is superior to treatment with…
The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella® mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5®…
The purpose of this prospective, pivotal, multi-center, single-arm cohort, pre-market, investigational clinical study is to assess the safety and performance of Deternia* Self-Gripping Resorbable Mesh when used for suture line reinforcement after…
This study has several objectives, in different (subsequent) study phases:• A1. Optimize and validate the technology of the VD to reach non-inferiority• B1. Demonstrate non-inferior performance and safety of the VD, for CE marking• B2. Demonstrate…
Primary objective of this clinical investigation is to evaluate superiority of the signal quality of SOFT ECoG flexible high-density electrode grids compared to regular high-density electrode grids, routinely used at the UMC Utrecht. The signal…
The Check@Home consortium aims to set up a roadmap and infrastructure for a (cost-)effective program to early detect atrial fibrillation and chronic kidney disease (defined by elevated albuminuria) in the general population. Furthermore, the…
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…
The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.
Primary Objective:- To compare adenoma detection rate (ADR) with versus without real-time automated detection (CAD EYE, Fujifilm)Secondary Objectives:- To compare the size, morphology and histology of adenomas detected and resected in both arms of…
The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB…
Primary Objective:Our overall aim is to develop an easy-to-use, and interpretive method for the early detection of valvular heart disease and thoracic aortic aneurysm based on arterial blood pressure waveforms, collected non-…