Transcatheter Aortic Valve Replacement with the Medtronic Transcatheter Aortic Valve Replacement System in Patients at Low Risk for Surgical Aortic Valve Replacement

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Phase: Pivotal
Status: Not Recruiting

The aortic valve is one of the four heart valves that control the flow of blood into and out of the heart. It is located in the main pumping chamber of the heart, called the left ventricle. The aortic valve allows oxygen-rich blood to be pumped out of the heart, from the left ventricle into the aorta (main artery delivering blood to the body). Aortic stenosis occurs if the area in the valve where the blood flows through becomes too small, and the heart must work harder to pump the same amount of blood with each beat. As the heart works harder, the heart muscle thickens (hypertrophy), and the heart chamber (ventricle) may become larger (dilate).

Open heart surgery or Surgical Aortic Valve Replacement (SAVR) to replace the diseased aortic valve is the standard treatment for aortic stenosis. As an alternative to open heart surgery, the study device in this trial has been developed to replace the diseased aortic heart valve without the need for open heart surgery. The study device called the Transcatheter Aortic Valve Replacement (TAVR) is inserted through a flexible tube (catheter). The catheter is inserted through an incision in the skin and threaded through the bloodstream.

This is a randomized trial meaning that after the screening process, a patient has a 50/50 chance of being randomized to the group receiving a study device (TAVR) or the group undergoing standard of care, open heart surgery (SAVR). The study will involve up to 1,200 participants, and may be conducted at up to 100 hospitals in the United States and several international hospitals. El Camino Hospital expects to enroll around 30 participants at this site.

The Medtronic CoreValve TAVR system is approved by the FDA for use in patients considered extreme or intermediate risk for complications with open heart surgery. This trial will evaluate the safety and effectiveness of the Medtronic Transcatheter Aortic Valve Replacement system (CoreValve, Evolut R and TAVR 2.0 systems) in patients with aortic stenosis who are at low predicted risk for complications with surgical aortic valve replacement (SAVR).

Patients in this trial will be required to participate in baseline and discharge testing, as well as return for 30 day, 6 month, 1 year, 18 months and annual visits with the study investigator for 10 years.

If you are a patient with aortic heart disease speak to your doctor to determine whether you are a candidate for participation in this study.