Active Clinical Trials 

CoreValve® U. S. Pivitol Trial (closed to enrollment, F/U through 5 years post implant)

Dr. Mamdouh Bakhos, Dr. J. Michael Tuchek, Dr. Ferdinand Leya

Summary:

Medtronic CoreValve® U.S. Pivotal Trial is a research trial for patients with a disease of their aortic valve called aortic stenosis. The risk category determined by your doctors, either high risk or very high/extreme risk, will determine the treatment received.

For some patients, the risk of experiencing major complications during open heart surgery is high. These patients are considered high risk to have an operation. The standard treatment for high risk patients with symptoms of severe aortic stenosis is an open heart operation to replace the diseased aortic valve. participate in this research you will randomized (like the flip of a coin) to receive either the transcatheter aortic valve implant (TAVI) or you will have open heart surgery to replace your aortic valve (SAVR). Neither you nor your doctor will be able to choose which type of treatment you receive. You will not be able to choose your treatment assignment.

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). High/extreme risk will not be randomized and will be in the TAVI treatment group.

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.

Medtronic CoreValve® Continued Access Study (High Risk and Extreme Risk Patients) AKA CAS Study (closed to enrollment, F/U through 5 years post implant)

Dr. Mamdouh Bakhos, Dr. J. Michael Tuchek, Dr. Ferdinand Leya

Summary:

Medtronic CoreValve® Continued Access Study (High Risk and Extreme Risk Patients) is a research trial for patients with a disease of their aortic valve called aortic stenosis. In this trial, both risk groups receive the transcatheter aortic valve implant (TAVI).

For some patients, the risk of experiencing major complications during open heart surgery is high. These patients are considered high risk to have an operation. The standard treatment for high risk patients with symptoms of severe aortic stenosis is an open heart operation to replace the diseased aortic valve.

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). High/extreme risk will not be randomized and will be in the TAVI treatment group.

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.

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 (HVAD LATERAL)

Dr. Edwin McGee (contract not yet executed)

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.