124 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…
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:…
To evaluate the safety and performance of the TriCinch System* in the treatment of functional tricuspid regurgitation
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 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…
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…
To demonstrate the safety and performance of the SMT Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
To determine the effects of surgical and transcatheter (transapical, transfemoral or transaortal) aortic valve replacement on patient neuropsychological functioning which provides the opportunity to prematurely establish subclinical effects that may…
To evaluate the safety and performance of the Lotus Valve system for transcathether aortic valve replacment (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
To evaluate long-term outcome of the Freestyle bioprosthesis in the aortic position
Bloodloss study after Aortic valve replacement
Impact of Mecc perfusion vs conventional ECCperfusion
Peri-operative Bloodloss after Aortic valve replacement
Predicting fluid responsiveness during PLR and fluid challenge (FC) by changes in (Pms).
To demonstrate the safety and performance of the Embolic Deflection Device (TriGuard*HDH) in patients undergoing Transcatheter Aortic Valve Replacement (TAVI).
To determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for non-invasive 2D stress echo testing are of utmost…