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Transcatheter Aortic Valve Replacement (TAVR) in Patients with the Medtronic Transcatheter Aortic Valve Replacement System in Patients at Low Risk for Surgical Aortic Valve Replacement (SAVR) Continued Access Trial

Study Type/Phase: Prospective, non-randomized, continued access trial
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), is the standard treatment for patients with severe aortic stenosis who are at low predicted risk for experiencing major complications while undergoing open heart surgery to replace the aortic valve. As an alternative to open heart surgery, the therapy being studied in this trial, transcatheter aortic valve replacement (TAVR), involves replacing the diseased aortic heart valve without the need for open heart surgery. The TAVR device is inserted through a flexible tube (catheter).

This trial will evaluate the safety and effectiveness of the Medtronic TAVR system (Evolut R and Evolut PRO systems) in patients with severe aortic stenosis who are at low predicted risk for complications with SAVR. The Medtronic TAVR system is approved by the United States Food and Drug Administration (FDA) for use in patients considered extreme, high, or intermediate risk for complications with open heart surgery.

Patients in this trial who meet eligibility requirements will be required to complete baseline and discharge testing, and return for 30 day and 1 year visits following implantation of the study device. During years 2- 10, participants will undergo passive follow-up, meaning that no pre-scheduled physician visits or testing will be required. Instead, information regarding the routine medical care you receive during this time that is specifically related to your heart valve will be gathered from information your physician normally collects and submits to the Center for Medicare and Medicaid.

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

Principal Investigator

Ajanta De, MD and Pei Tsau, MD

Sponsor

Medtronic, Inc.
CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.

NCT Number

NCT02701283

Contact

Janet Lamm, Clinical Research Coordinator
650-962-4566
Janet_Lamm@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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