63 results
To evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline hydration prior to TAVI in patients with CKD to prevent CIN.
The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on periprosthetic aortic regurgitation and additional focus on other clinical and…
The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus* Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered…
Compare hemodynamic parameters and flow patterns of the stented Mitroflow bioprosthesis, stentless Freedom SOLO bioprosthesis,transcatheter Edwards Sapien bioprosthesis and healthy control subjects, measured with 4D flow MRI.
The primary objective is to investigate cerebral perfusion in rest and in response to moderate exercise (handgripping or light cycling) and a visual stimulus in patients with severe aortic valve stenosis prior and after surgical or transcatheter…
Assess if CIN prophylaxis for CTA and a TAVI procedure with a 1 -hour sodium bicarbonate protocol is non-inferior in terms of decline in eGFR and serum creatinine level to the 24 hour saline protocol. in pre-operative screening for TAVI and actual…
The purpose of this investigation is to evaluate decellularized homograft for aortic valve replacement (ARISE AV) rates in comparison to current valve substitutes within a large prospective multicentre surveillance at 6 leading European Centres for…
We aim to i) describe flow patterns and flow-related dynamics in the ascending aorta of patients with aortic valve stenosis, ii) compare these flow parameters before and after surgical aortic valve replacement and iii) compare flow parameters with…
To evaluate the safety & efficacy of automatic valve plane tracking for the deployment of transcatheter bioprostheses.
To further study the safety and effectiveness of the MitraClip system in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class III or Class IV chronic heart…
The objective of the BRAVO 2/3 study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
The Claret device (Claret Inc.) is an Embolic Protection Device (EPD) consisting of two nitinol baskets to be introduced through the right radial artery. One basket is positioned in the brachiocephalic trunk, the other in the left common carotid…
To compare early mitral valve repair versus watchful waiting.
To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI.
Conduct a multicenter randomized clinical trial to assess whether the use of the decision aid results in optimization of shared-decision making and improved quality of life in patients who have been accepted for aortic and/or mitral valve…
The purpose of this investigation is to evaluate the ESPOIR PV in comparison to current valve substitutes within a large prospective multicentre surveillance at 8 leading European Centres for Congenital Cardiothoracic Surgery regarding re-operation…
To investigate whether an endothelin-1 receptor antagonist improves exercise capacity (peak V*O2) in adults with CHD or with mitral valve lesions who undergo cardiac surgery.
Primary objectives:- Evaluation of the value of mBL as a diagnostic tool for bacterial endocarditis.- Evaluation of the value of mBL as a monitoring tool during treatment for bacterial endocarditis.- To obtain data on the kinetics of mBL related to…
The primary objective of this study is to identify mutations associated with the development of a bicuspid aortic valve. To this end the study will focus on genes important for aortic valve formation. As an extension of the primary objective, a…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…