5 results
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
Primary Objective:• To evaluate the safety and tolerability of danavorexton single IV infusion administered in healthy subjects undergoing OIRD.Secondary Objective:• To assess the PK of danavorexton single IV infusion administered in healthy…
The FAST Therapy Trial is a prospective trial of patients with a new diagnosis of fetal SVA aimed to compare the impact of different perinatal treatment strategies from the time of SVA diagnosis to birth or death1) The primary outcome will be the…
Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands
To study whether low-level digoxin reduces the composite primary endpoint of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular mortality, compared to placebo, in chronic HF.