The MIST II trial intends to investigate the effect of a STARFlex device on migraine headaches in people with a congenital heart disorder called patent foramen ovale (PFO). PFO is a condition in which a small flap-like opening in the atrial septum, the muscular wall that separates the two upper heart chambers, fails to seal after birth. The condition has been linked to migraine headaches and stroke. Study participants, all of whom have PFO and experience migraine headaches, will be randomly assigned to two groups. One group will undergo PFO closure with the STARFlex device, one group will serve as a control group. The study is being conducted in up to 20 centers across the United States and approximately 610 patients will be enrolled in this study.
For the Protect AF study, researchers are testing the WATCHMAN® device in people with atrial fibrillation (AF). Atrial fibrillation is a heart rhythm disorder in which the heart's upper chambers, the atria, beat in an uncoordinated manner instead of beating efficiently. Because of the reduced efficiency of the atria in people with AF, blood can pool and blood clots can form. A clot that enters the bloodstream can travel to the heart and cause a stroke. The device is designed to keep these blood clots from entering the bloodstream. Protect AF will enroll as many as 1000 subjects at 60 medical centers in the United States.
View: View our video of the WATCHMAN® left atrial appendage system is designed to keep harmful sized blood clots that form in the left atrial appendage from entering your blood stream, potentially causing stroke (blockage of blood to brain) or other complications.
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS II)
This trial will test the effectiveness of the HeartPOD TM Heart Failure Management System with DynamicRx TM (HeartPOD System) in patients with severe chronic congestive heart failure (CHF). The HeartPOD System is an implantable device that monitors certain heart functions in people with CHF and then transmits the information to a handheld device called a Patient Advisory Module (PAD). The information transmitted from the HeartPOD System to the PAD enables the patient to adjust his or her medication levels for each dose.
This trial will compare the ZoMAXX drug-eluting stent to the TAXUSTM Express2 TM Paclitaxel-Eluting Stent in preventing restenosis in arteries. The trial will enroll approximately 1670 patients at 75 US centers and up to 10 international sites.
When a blocked artery has been reopened after causing a heart attack, the body can release a large amount of nitric oxide into the bloodstream. In small amounts, nitric oxide is good for the body, but in large amounts it can add to heart attack damage, decrease the heart's ability to pump blood efficiently, and lower blood pressure in the body's organs and reduce the amount of blood the organs receive. This study, which will enroll 658 subjects in 120 medical centers worldwide, will test the effectiveness of tilarginine acetate in temporarily lowering the amount of nitric oxide released into the body's organs following a heart attack. Study subjects will be randomly assigned to two groups. The first will receive Tilarginine Acetate Injection, and the second group will receive a placebo.
(Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome [EARLY ACS])
This study will enroll 10,500 patients at 500 study sites worldwide. Subjects will be randomly assigned to a control group and a group in which the subjects receive Integrilin to measure Integrilin's effectiveness in reducing death and other major adverse cardiac events, including heart attack, within 96 hours and up to 30 days.
(Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel disease)
This study is to measure the 5-year mortality rates of people who have diabetes and coronary artery disease in more than one coronary artery. The study will enroll 2,400 people from 100 medical centers in the United States, Europe, South America, and Australia. The subjects will be randomly assigned to undergo coronary artery bypass graft surgery or angioplasty.
LHHVI is looking for study participants for the above and other studies. Participating in a study is a way for people to contribute to improved understanding and treatment of diseases, although study participants may not gain any direct benefit from participating in a study. For more information, please contact the Clinical Research Coordinators representing the following subspecialties: