4 results
The primary objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA* Reinforced Reload with Tri-…
The objective of this clinical investigation is to assess and characterize the clinical management of HeartMate 3 LVAD patients guided by hemodynamic parameters provided by the CardioMEMS HF System as a clinical hybrid construction to optimize…
Primary:* To describe the effect of the new thermo stable formulation of FLOLAN on quality of life in patients switching from the currently marketed FLOLAN to the new thermo stable formulation.* To determine the dose titration requirementSecondary…
We hypothesize that the CardioMEMS HF system will be safe and superior to standard care in improving the quality of life and health status in patients with chronic HF in the Netherlands. Additionally, we hypothesize the CardioMEMS HF system is cost-…