The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure.
ANNEXa-1 (18-513): This is a randomized, multicenter clinical trial designed to determine the efficacy and safety of andexanet compared to usual care in patients presenting with acute intracerebral hemorrhage within 6 hours of symptom onset (from the baseline scan) and within 15 hours of taking an oral FXa inhibitor (from randomization). The study will use a prospective, randomized, open-label design, as it is unfeasible to blind the Investigator to the treatment assignment given the many potential therapeutic options available under usual care treatment.
The RECOVER study is a nationwide clinical trial that has been approved by Medicare to provide additional evidence for the benefits of Vagus Nerve Stimulation (VNS) Therapy. Vagus Nerve Stimulation Therapy is an FDA-approved device for treating patients with TRD (Treatment Resistant Depression). It is implanted in the left chest area during a short outpatient procedure. The device delivers mild, intermittently pulsed signals to the vagus nerve in the neck that activate various parts of the brain.