CoreValve is a Transcatheter Aortic Valve Implantation (TAVI) procedure, a minimally invasive treatment option for people with severe aortic stenosis. It is considered an investigational device, which means that clinical studies are required to determine if it is safe and effective treatment for aortic stenosis.
The CoreValve System is not currently available for commercial use in the United States. In 2010, the FDA approved its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation.
The CoreValve System received Conformité Européenne (CE) Mark in 2007, and it has been implanted in patients in more than 35 countries outside the U.S. since then.
Approximately 300,000 people worldwide suffer from severe aortic stenosis, which occurs when the heart’s aortic valve is narrowed, restricting blood flow from the heart to the body. The condition primarily affects older people and typically develops in individuals between the ages of 50 and 70.
The standard treatment for severe aortic stenosis is open-heart valve replacement surgery. Recent research shows that, left untreated, severe aortic stenosis has about a 50 percent mortality rate at one year. A significant number of severe aortic stenosis patients are at high risk for open-heart surgery, and one-third are altogether ineligible for open-heart surgery. The Medtronic CoreValve U.S. Clinical Trial will evaluate the safety and effectiveness of the CoreValve Transcatheter Aortic Valve System in these groups of patients.
The CoreValve aortic heart valve is made of natural tissue obtained from the heart of a pig. The leaflets that control the flow of blood in the CoreValve heart valve are secured to a flexible, self-expanding frame for support. With CoreValve TAVI, an incision is made in the femoral artery (in the groin area), and a new aortic valve is delivered via a catheter (a thin, flexible, hollow tube). It is a less invasive treatment option than open-heart valve surgery.
The CoreValve clinical study involves more than 1,200 patients at up to 40 hospitals in the United States. El Camino Hospital is an approved, official site for the CoreValve clinical trial. Prior to participation in the CoreValve clinical study, you will need to sign a consent form. The study is randomized, meaning the process of selecting who will receive CoreValve is indiscriminate or arbitrary.
Potential benefits to study participants include improved heart valve function and blood flow, and reduced symptoms of aortic stenosis (chest pain or tightness, feeling faint or fainting with activity, dizziness, fatigue, shortness of breath, heart palpitations, heart murmur).
Read more about the study.
Purpose of the Research
The purpose of the trial is to assess the safety and performance of a new approach to aortic valve replacement. The valve being studied has been developed for patients with severe aortic stenosis.
Who is Eligible to Enroll?
Patients with severe aortic stenosis who are at high risk or at very high risk for standard open heart surgery may qualify to take part in the clinical trial. If chosen for the trial, more testing is done to determine eligibility. In a randomized trial, patients will learn if they will receive transcatheter aortic valve implantation only after they have first been enrolled in the clinical trial and then assigned for one of the treatments in the trial. Only your doctor can decide if you are a good candidate for the clinical trial.
Note: There is no age limitation for the clinical trial, however most patients are 75 years or older.
Prior to taking part in the clinical trial, patients must go through tests and evaluations including: a standard physical examination, routine laboratory tests, electrocardiogram (EKG) and catheterization.
How Do I Get into the Clinical Trial?
Patients who have been diagnosed with severe aortic stenosis and who are candidates for open heart surgery may be referred by their doctor to participate in the trial. Patients must be referred by their doctor.
What is the Visit Schedule?
As part of this clinical trial, you will be expected to participate in follow-up evaluations. Follow-up visits are at 30 days, 6 months, and annually for 5 years. These visits are needed to check your heart valve function and will take place at your doctor’s office.