About six years ago, Roy was told by his doctor that he needed to have major heart surgery to treat his severe aortic stenosis, a narrowing of the valve opening that restricts blood from the heart to the rest of the body, or his life was in jeopardy. The trouble was, at 87 years old, Roy’s age put him at risk for traditional open-heart surgery, which involves breaking the chest open and months of recovery.
At about the same time, several doctors at El Camino Hospital were conducting a clinical trial for the Medtronic CoreValve® System, which allows doctors to replace a diseased aortic heart valve through a minimally invasive procedure. The artificial valve is inserted without open-heart surgery and without removal of the diseased valve. Instead, a catheter fitted with the device is guided through an incision in your upper thigh or chest area and through the artery connected to the heart. The system expands once it is in place and takes over the original valve's function, enabling blood to flow efficiently out of the heart.
Roy’s doctor suggested the clinical trial of the CoreValve System as a viable alternative for him. At the urging of his doctor, Roy and his wife Marilynn contacted Dr. James Joye, an interventional cardiologist who was the co-primary investigator of the CoreValve Continued Access study clinical trial at El Camino Hospital.
“Dr. Joye was very helpful and comforting throughout the entire process,” said Marilynn. “We had a lot of confidence just from his manner. He is polite and respectful and kind.”
During the follow-up phase of the trial, Roy had follow-up visits with Dr. Joye once a year. Now, five years post-procedure, he no longer needs these regular check ins.
“The whole process of participating in a clinical trial was smooth and has given me a new lease on life” says Roy, who is very active in his retirement community. “I serve as the treasurer in our community, and we are involved with our church – we lead an active life that maybe wouldn’t be possible if it wasn’t for the CoreValve trials at El Camino Hospital.”
The CoreValve Continued Access trial conducted at El Camino Hospital helped lead to U.S. Food and Drug Administration (FDA) approval of the system --a significant milestone for patients with severe aortic stenosis.
“We are both so happy that we were a part of the process that has helped make this procedure available for other patients in Roy’s situation,” says Marilynn.
This is one patient's story, individual results may vary. Speak with your doctor to determine care that’s right for you.