LU#204710
Medtronic CoreValve® U.S. Expanded Use Study
Dr. Mamdouh Bakhos, Dr. J. Michael Tuchek, Dr. Ferdinand Leya
Summary:
Medtronic CoreValve® U.S. Expanded Use Study is a research trial for patients with a disease of their aortic valve called aortic stenosis and are considered extreme risk or at very high risk to have an operation. Open-heart surgery to replace the diseased aortic valve is the standard treatment. For some patients, the risk of experiencing major complications during open-heart surgery is very high. The standard treatment for extreme risk patients with symptoms of severe aortic stenosis is medical management, which may include balloon valvuloplasty.
If your doctors have determined that your risk of experiencing major complications while undergoing open-heart surgery is very high due to medical reasons or anatomical (relating to how and where your heart, aortic valve and blood vessels are placed within your body) reasons you are considered extreme risk (at very high risk to have an operation). As an alternative to medical management, the Medtronic CoreValve® System has been developed to replace a diseased aortic heart valve without the need for open heart surgery. This system allows the percutaneous aortic valve (study valve) to be implanted (inserted) through a long, thin flexible tube that is inserted through an incision in the skin and threaded through the bloodstream (percutaneous). This procedure is called transcatheter aortic valve implant (TAVI).
The study valve is considered an “investigational device”, which means that clinical studies are required to determine if it is safe and provides clinical benefit. Medtronic, Inc. is sponsoring this study to obtain data on the safety and performance of the Medtronic CoreValve® System. The Medtronic CoreValve® System includes the valve and two parts that help load and deliver the valve correctly. Based on your current medical condition, you may be a candidate this new therapy.
LU#204097
Medtronic CoreValve SURTAVI Study
Dr. Mamdouh Bakhos, Dr. J. Michael Tuchek, Dr. Ferdinand Leya
Summary:
The SURTAVI (SURgical and Transcatheter Aortic Valve Implantation) Study is a research trial for patients with a disease of their aortic valve called aortic stenosis and are considered intermediate risk to have an operation. This purpose of the SURTAVI clinical study is to determine if replacing the aortic valve without open-heart surgery is as safe as or safer than open-heart surgery in patients with similar medical conditions which have an intermediate risk with a surgical risk score from 3-10%. This means that your doctor believes your health is acceptable for open-heart surgery, but there are still risks of potential problems.
Patients in this category have a 3-10% risk of mortality/death if they undergo aortic valve open heart surgery. This is a standard electronic calculation that cardiovascular surgeons use for risk calculations in heart surgeries for all patients.
The Medtronic CoreValve® System has been developed to replace a diseased aortic heart valve without the need for open heart surgery. This system allows the percutaneous aortic valve (study valve) to be implanted (inserted) through a long, thin flexible tube that is inserted through an incision in the skin and threaded through the bloodstream (percutaneous). This procedure is called transcatheter aortic valve implant (TAVI).
If your doctors and the committees determine you are eligible to be in the study your treatment will be determined in a way similar to flipping a coin, called randomization. Your chances of being assigned to either of the treatments are equal. You will be assigned to one of two groups. One group will receive a transcatheter aortic valve implant (TAVI), the other group will receive open-heart surgical aortic valve replacement (SAVR). Neither you nor your doctors will not be able to choose your treatment assignment.
The study valve is considered an “investigational device”, which means that clinical studies are required to determine if it is safe and provides clinical benefit. Medtronic, Inc. is sponsoring this study to obtain data on the safety and performance of the Medtronic CoreValve® System. The Medtronic CoreValve® System includes the valve and two parts that help load and deliver the valve correctly. Based on your current medical condition, you may be a candidate this new therapy.
LU#207229
HVAD LATERAL A Prospective, Single Arm, Multi-Center Clinical Study in Collaboration With the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD® System in Patients With Advanced Heart Failure
Dr. Edwin McGee
Summary:
The HeartWare® HVAD System is a left ventricular assist device (LVAD) that has been approved by the Food and Drug Administration (FDA) for patients awaiting heart transplantation. An LVAD is a mechanical pump that connects to your heart and assists it by taking over some of the work of pumping blood. The LVAD will assist your heart to provide your body with blood flow which is necessary to live.
The standard and approved method for implanting LVADs, including the HVAD, requires division of the entire breast bone and is called a sternotomy, where an incision is made in the breast bone (a long flat bone in the middle of your chest) to open your chest to implant an LVAD in your heart.
In this research project, the implant of HeartWare® LVAD in your heart will be done using a different type of incision called a thoracotomy incision. This means that a cut or incision is made near your ribs to open your chest in order to implant. A second incision will be made either in the sternum (partial sternotomy) or an additional thoracotomy is required to attach the HVAD to the aorta, the main blood vessel that leaves the heart.
The HeartWare® HVAD System has been approved by FDA when implanted using a sternotomy incision. The purpose of this study is to evaluate the safety and effectiveness of implanting the HeartWare® HVAD in patients who are to receive the HVAD using a potentially less invasive approach called thoracotomy. Implantation by thoracotomy is investigational or research.