The purpose of this study is to gather more information about how effective the Amplatzer Septal Occluder is at closing an atrial septal defect. Atrial septal defect (ASD) is a congenital (occurring at birth) heart defect in which the wall that separates the upper heart chambers (atria) does not close completely. The study is also being done to collect information about the safety of the device. The study is being conducted at up to 30 medical centers across the United States.
CLOSURE I - Is a Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Starflex Septal Closure System versus Best Medical therapy in Patients with a Stroke and/or Transient Ischemic Attach due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale.
There are two objectives for this study. First, to learn if the study device, when placed in the heart, will safely and effectively prevent a recurrent embolic stroke or TIA (transient ischemic attack) in patients with a patent foramen ovale (PFO). Second, to compare the study device to the best medical therapy. Best medical therapy is the use of aspirin, Coumadin, or a combination of both.
If all eligibility criteria are met, patients are randomized to study device placement or best medical therapy. Clinical follow-up for all patients is at 1, 6, 12 and 24 months post-enrollment.
This study examines the safety and effectiveness of two different drug-eluting stents (CoStar(R) and TAXUSTM) in patients with symptomatic heart disease. Participants will have blockage(s) in one, two or three of their heart or coronary arteries as determined by angiography. They will be randomized to receive either the TAXUS stent (coated with paclitaxel) or the CoStar stent (paclitaxel loaded into reservoirs located within the stent struts). Participants in the trial will be followed for a period of 5 years.
Patients who are not candidates for heart transplant owing to age or other diseases and have been treated with all medical management available and are still in danger of dying are implanted with this centrifugal force pump. The patient is randomized to the study device or the only approved device for DT, the HeartMate XVE LVAD. The device is designed to support their heart for years. The patient will be followed for the rest of his life.