Structural Heart Disease

CAP2: Continued Access to PREVAIL

Short Description: A non-randomized study to allow continued access to the WATCHMAN LAA Closure Technology during Pre-Market Application by FDA. Intended for subjects with non-vavluvlar Afib that want to stop anticoagulation. The WATCHMAN® Left Atrial Appendage Closure Technology is intended for patients with non-valvular atrial fibrillation who require treatment for potential thrombus. It is designed to prevent the embolization of thrombi that may form in the left atrial appendage (LAA and may prevent the occurrence of ischemic stroke and systemic thromboembolism in this patient population. The use of the WATCHMAN device may reduce the risk of lifethreatening bleeding events such as hemorrhagic stroke.

Principal Investigator: Robert Sommer, MD

http://www.clinicaltrials.gov/ct2/show/NCT01760291?term=CAP2&rank=1

REDUCE: GORE HELEX™ Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO)

Short Description: This study will examine whether patent foramen ovale (PFO) closure with the investigational GORE Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or transient ischemic attack (TIA) when compared to anti-platelet medical management alone in patients with a PFO and history of cryptogenic stroke or TIA. When a person has a stroke or TIA "out of the blue" with no obvious risk factors, doctors often check to see if the patient has a hole in the heart called a PFO. All people are born with flap-like openings in their hearts. For most, the opening closes by itself shortly after birth. In some people, an open flap remains between the two upper chambers of the heart (the left and right atria) and this opening or hole is referred to as a PFO. About 1 in 5 Americans has a PFO. Presently, a causal relationship between PFO and cryptogenic stroke or its recurrence remains open to debate. The standard treatment for cryptogenic stroke is antiplatelet therapy. However, this can increase the risk of bleeding complications and may not prevent recurrent ischemic neurological events. If the patient qualifies for participation, they will be randomized. Patients will have a 2-in-3 chance of being randomized to the test (device) arm.

Principal Investigator: Robert Sommer, MD

http://www.clinicaltrials.gov/ct2/show/NCT00738894?term=gore+reduce&rank=1