This is a prospective, multicenter, open-label, single-arm study that seeks to confirm and describe the safety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study. It is also designed to demonstrate acceptable performance of the GSO device in patients treated with percutaneous, transcatheter PFO closure plus anti-platelet medical…
This clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of…
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping…
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or…
This is a multicenter, prospective randomized study to determine the safety and efficacy of the Watchman device in patients with irregular heart beat undergoing a less invasive procedure than open heart surgery called Transcatheter Aortic Valve Replacement (TAVR). In this procedure, an x-ray is used to visualize and guide the Watchman device via a catheter…