81 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.
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…
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
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…
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.…
In this study we want to assess the structural THV integrity in situ and to identify the respective accommodation patterns of the different THV platforms and the interaction with the aortic root in situ.
The study objective is to evaluate the clinical outcome of percutaneous aortic valve implantation in consecutive *real world* patients with severe aortic valve stenosis intended to be treated with the Medtronic CoreValve System.
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S-valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis. The…
The objectives of this study are to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing aortic valve replacement (AVR). The AVR surgical approach is either full or…
The main objective is to assess the effects of TAVI on cardiac sympathetic activity.
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 objectives of this study are to:• To demonstrate the safety of the InSeal VCD implant. • To demonstrate the safety and functionality of the InSeal VCD delivery system in delivering and deploying of the InSeal VCD implant and withdrawal of the…
The objective of the study is to demonstrate the safety, feasibility and potential efficacy of using GDS Accucinch System in human subjects with heart failure and clinically significant functional mitral regurgitation.