Advances in medicine and science are the results of new ideas developed through research. New cardiac treatments must prove to be safe and effective in scientific studies before they can be made widely available to patients. By performing clinical trials we learn which treatments are more effective than others. The standard treatments we use today were first shown to be effective in clinical trials. These trials helped to find new and better treatments.
Through active involvement in cardiac research, Providence Heart and Vascular Institute is making better treatments, faster recovery, and longer-lasting results a reality for people with heart disease. Here patients can access the latest therapies, which are currently available only through clinical trials.
Clinical trials currently underway at Providence Heart and Vascular Institute include:
Drug-coated/eluting stents
Providence Heart and Vascular Institute has been instrumental in the research and evaluation of drug-coated/eluting stent therapy and continues with studies of this developing technology. Drug-coated stents have been shown to reduce the incidence of restenosis or reclosure of heart vessels requiring stenting.
This is a study of an investigational embolic protection device called the ProxisÔ Embolic Protection System developed by Velocimed, Inc. It is used to remove particles break away from arterial blockage during balloon angioplasty or stent placement. The device is different from other embolic protection devices because it is placed in the vessel before starting the treatment to open the blockage. This may help to prevent the release of plaque debris.
SISR study
This is a study of the CypherÔ sirolimus-eluting stent, made by Cordis for the treatment of re-closure of a heart blood vessel that has previously been treated with a standard non-drug-coated stent.
Over a period of several weeks or months, the inner lining of the blood vessel grows over the stent surface, and the stent becomes a permanent part of the blood vessel. Re-closure or restenosis of the blood vessel after putting in a stent happens in twenty percent to thirty percent of all patients who receive stents. This is because too much tissue grows in and around the stent.
Patients in this study will receive one of the two treatments to try to reopen the heart vessel: either the CypherÔ stent or Brachytherapy treatment. Brachytherapy treatment uses radiation given through a catheter inside the narrowed vessel.
CarboMedics Mitroflow Valve study
This is a study of an investigational heart valve. The Mitroflow valve is a tissue valve made by CarboMedics. The Mitroflow valve is used in heart valve replacement surgery outside the United States since it was introduced in1982. About 33,000 people have received the valve. The purpose of this study is to show the safety and effectiveness of the Mitroflow valve in a study done in the U.S.
Myocor RESTOR MV trial
This is a study of an investigational device called Coapsys made by Myocor, Inc. The device is used to treat mitral valve regurgitation, a condition in which blood leaks from the left ventricle (lower chamber) back into the left atrium (upper chamber), making it difficult for the heart to pump blood effectively. The Coapsys device works by changing the shape of the mitral valve allowing it to close more effectively and perhaps correct mitral valve regurgitation.
Heart failure
Providence Heart and Vascular Institute is involved in clinical trials of approved and investigational drugs and devices for the treatment of heart failure. These include studies of new technologies in the area of cardiac resynchronization. These systems coordinate the pumping action of the heart to make the ventricles contract simultaneously. By improving ventricular coordination, or re-synchronizing them, researchers hope to diminish heart failure symptoms.
