7 results
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 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…
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…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
To demonstrate the safety, efficacy, and performance of the Edwards Lifesciences MONARCTM system for the treatment of functional mitral regurgitation
LANDMARK Trial is designed to compare safety and effectiveness of Meril*s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards* Sapien THV series and Medtronic*s Evolut THV series) in patients with severe symptomatic native…
The objective in the vanguard phase of the LIMIT trial is to assess the feasibility of recruiting 400 subjects over approximately 3 years at 5 centres. The objectives in the full trial are to evaluate the safety and efficacy of a common, lower INR…