179 results
2.1 Primary objectiveTo determine patterns of response in the transvalvular pressure gradient while altering transvalvular flow.2.2 Secondary objectives-To quantify any added value or differentiation from stress assessment of aortic stenosis…
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 purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Primary objective: To validate the quantification of AR by time-densitometry on contrast aortography with the gold standard of CMRI measurements in order to refine the interpretation and evaluate the accuracy of the qRA method. Secondary objective:…
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 objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a…
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…
To evaluate the safety and performance of the TriCinch System* in the treatment of functional tricuspid regurgitation
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 clinical investigation is to further assess the performance and safety profile of the commercially available Portico Valve implanted, using the Delivery System and the Loading System, in patients with severe symptomatic aortic…
To determine normal FDG-uptake around PHV*s in aortic position.
To study the biological variation of cardiac biomarkers (e.g. cardiac troponin T and I, NT-pro-BNP, ST-2, Galectin-3) in clinically stable moderate aortic valve stenosis.
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…
The objectives of this study are to evaluate the safety and performance of the valve and delivery systems for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation in a prohibitively high risk patient…
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…
The purpose of Part 1 of the research is to look at the usability and accuracy of the automatically determined CT visualizations and measurements.The purpose of Part 2 of the study is to determine whether the use of the combined information provides…
The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are…
* Confirm device safety and performance* Confirm implant procedure and therapy adjustment procedure safety and performance
The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the Hancock® Ultra* bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch and the correlation of…