Interventional Cardiology and Valvular Heart Disease
This clinical trial is for men and women diagnosed with ischemic heart disease (myocardial ischemia) who are eligible to be treated with coronary angioplasty (PCI). Eligible patients include persons with angina (stable, unstable, or post-infarct), or silent ischemia.
The purpose of the study is to evaluate the safety and effectiveness of the Absorb Bioresorbable Vascular Scaffold (BVS) System made by Abbott Vascular. Unlike traditional metal stents which remain in the body permanently, the Absorb BVS dissolves into the blood vessel, leaving behind a treated vessel that is free of a permanent metallic implant.
Study subjects will be randomized to receive either the Absorb BVS or a commercially approved stent, and will be followed up for 5 years.
This clinical trial is for men and women who are diagnosed with mitral regurgitation (MR), mitral insufficiency or mitral incompetence and are at extremely high risk for open mitral valve surgery.
The purpose of the study is to assess the safety and effectiveness of the MitraClip device, the first device for repair of the mitral valve that is delivered by a catheter, avoiding the need for heart surgery. Half of the eligible study subjects will be randomized to undergo the MitraClip procedure, and the other half will continue to be treated according to standard medical care without the MitraClip procedure.
Study subjects will be followed up for 5 years after placement of the stent.
Enrollment in this trial is temporarily on hold.
This clinical trial is for men and women who are diagnosed with ischemic or congestive heart failure (CHF) after a myocardial infarction (MI or “heart attack”).
The purpose of the study is to assess the efficacy and long-term safety of the CardioKinetix Parachute device, an umbrella-shaped membrane that is is implanted inside the left ventricle of the heart. This creates a partition in the ventricle, reducing the effective size of the chamber and restoring its natural shape somewhat, which has been shown to be important for the treatment of heart failure. It is implanted with a catheter procedure, avoiding the risks of surgery.
Study subjects will be followed up for 5 years after placement of the stent.
This clinical trial is for men and women who are diagnosed with severe aortic stenosis and are at intermediate-risk for traditional open-heart surgery for aortic valve replacement.
The purpose of the study is to assess the safety and effectiveness of the SAPIEN XT and SAPIEN 3 transcatheter heart valves. Unlike traditional replacement aortic valves, they are implanted with a catheter procedure to eliminate the need for surgery. These devices are approved by FDA for patients who are at high-risk for traditional open-heart surgery.
Study subjects will be followed up for 5 years after placement of the stent.
This clinical trial is for men and women diagnosed with an atrial septal defect, which is an opening between the right and left upper chambers of the heart. As part of this study, the doctor will attempt to implant the AMPLATZER™ Septal Occluder (ASO) to close this hole. The ASO is approved by the FDA to close atrial septal defects. The device, procedures and tests used in this study are not considered experimental.
The purpose of the study is to gather more information about the possible risk factors associated with the occurrence of a rare type of negative effect, called erosion, and the presence of the implanted ASO device.
Study subjects will be followed up for 12 months after the placement of the ASO.
This clinical trial is for men and women diagnosed with coronary artery disease who qualify for stenting of coronary artery lesions.
The purpose of the study is to evaluate the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System made by Biotronik. This is a thin, flexible stent that is coated with a material that inhibits inflammation and cell proliferation, which may reduce adverse reactions compared to other metal stents.
Study subjects will be followed up for up to 5 years after placement of the stent.
This clinical trial is for men and women diagnosed with clinically significant functional mitral regurgitation who are determined to have an unacceptably high risk from surgery.
The purpose of the study is to evaluate the safety and effectiveness of the MitraClip System made by Abbott Vascular, Inc. The MitraClip System is the first FDA-approved mitral valve repair therapy that is percutaneous, meaning that access to the heart is gained by means of a catheter, as with angioplasty or stenting, rather than by an open heart surgery. This provides a treatment option for select patients with mitral regurgitation.
Study subjects will be randomized in a 1:1 ratio either to receive the MitraClip device, or to be treated without the device by standard medical care. Study subjects are followed up for 5 years.
This clinical trial is for men and women who will be treated with peripheral endovascular interventions (PEI).
The purpose of the study is to determine whether anticoagulation treatment with a drug called bivalirudin (manufactured by The Medicines Company under the trade name Angiomax®) results in fewer major bleeding complications compared with heparin in subjects undergoing PEI. Bivalrudin is an anticoagulant that may overcome many limitations seen with indirect thrombin inhibitors, such as heparin, by having a more predictable response, leaving the body more quickly, and avoiding conditions associated with the use of heparin such as thrombocytopenia.
Study subjects will be followed up for 12 months after the peripheral endovascular interventions .
This clinical trial is for men and women who will undergo coronary angiography, a minimally invasive catheter-based procedure to visualize the arteries that supply blood to the heart, whose procedure is likely to include IVUS (intravascular ultrasound imaging, which employs a miniaturized ultrasound probe attached to the catheter).
The purpose of this study is to determine whether detecting cholesterol-rich plaques in the coronary arteries using near-infrared light can predict future coronary problems for persons who have already experienced such problems. Study subjects will be followed up for 2 years after the coronary angiography procedure.
This clinical trial is for men and women age 18 and older who have severe aortic valve stenosis and are scheduled to undergo a Transcatheter Aortic Valve Replacement procedure ("TAVR," also known as Transcatheter Aortic Valve Implantation or "TAVI").
The purpose of the study is to evaluate the safety and efficacy of the Sentinel™ Cerebral Protection System made by Claret Medical, Inc. The Sentinel system is intended to capture and remove blood clots that may form during a TAVR procedure so as to protect the brain from possible damage due to blockage of the arteries that supply blood to the brain.
Study subjects will be followed up for 90 days after the TAVR procedure.