110 results
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.
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…
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…
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…
* 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 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
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).
Bloodloss study after Aortic valve replacement
Impact of Mecc perfusion vs conventional ECCperfusion
Peri-operative Bloodloss after Aortic valve replacement
The objective is to collect additional data on the clinical outcomes (surgical data, safety and clinical performance) of the Medtronic Enable® Aortic Bioprosthesis in *real world* patients. The collected data will be used to improve aortic valve…
To compare early mitral valve repair versus watchful waiting.
The main objective is to determine the early and late survival and reoperation outcome of VSARR in patients suffering from aortic root aneurysm with or without aortic regurgitation. Furthermore, we will evaluate the quality of using a SF-36 form.…
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…