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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

CARDIOX: FDS-0005 Controlled within Subject Comparison of Cardiox FDS Technology to Transesophageal Echocardiography (TEE) and Cardiox FDS Technology to Transcranial Doppler (TCD) for the Detection of Right-to-Left Shunts.

Short Description: The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal echocardiography (TEE). RLS intracardiac shunts are associated with a number of clinically important syndromes including paradoxical thromboembolism (causing stroke or other systemic infarct), migraine headaches (particularly with aura), desaturation with obstructive sleep apnea, and decompression illness. From a research perspective, the detection of shunts in subjects with these types of syndromes is critical in helping to define the role of RLS in these disease processes. From a clinical perspective, shunt detection will be increasingly important in an era where interventional procedures for repairing cardiac defects are available for subjects determined to be at risk.

Principal Investigator: Robert Sommer, MD

http://clinicaltrials.gov/ct2/show/NCT01773252?term=cardiox&rank=2

 

 

 

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