Spectrum Health Participating in Non-Surgical Heart Valve Clinical Trial

Patients sought for the non-surgical aortic valve replacement are those with severe aortic stenosis.

GRAND RAPIDS – Spectrum Health is participating in a clinical trial to evaluate a transcatheter alternative to open-heart surgery for patients with severe aortic stenosis.

The Medtronic CoreValve U.S. Clinical Trial is underway at the Fred and Lena Meijer Heart Center. The Meijer Heart Center is among approximately 40 hospitals across the U.S. that will participate in this trial. The trial is expected to last for five years.

The CoreValve System is designed to provide a minimally invasive, transcatheter treatment option for patients with symptomatic, severe aortic stenosis who are at high risk or are ineligible for open-heart surgery.

Worldwide, approximately 300,000 people have been diagnosed with this condition (100,000 in the U.S.) and approximately one-third of these patients are deemed at too high a risk for open-heart surgery, the only therapy with significant clinical effect that is currently available in the United States.

The valve replacement procedure channels a catheter (thin tube) with a prosthetic valve through the femoral artery to reach the heart. The CoreValve System is designed with self-expandable technology, deploying the valve inside the diseased aortic valve without open-heart surgery or surgical removal of the native valve.

Placing a catheter into an artery in the groin or shoulder is the most common approach in this procedure. In atypical cases, a catheter can’t be threaded through groin or shoulder arteries because of issues such as small arteries or previous grafts so a different approach is required.

Spectrum Health physicians were among the first in the country to take a novel investigational approach called direct aortic access. In this procedure, an incision is made in the chest to expose the aorta, the main artery of the heart. The catheter is placed directly into the aorta, maneuvered into the heart and then the valve is placed.

Only six direct access cases have been done in the U.S. and Spectrum Health has done three. Five heart centers in the country have been selected to initiate this approach.

This study is directed by two co-principal investigators associated with the Spectrum Health Frederik Meijer Heart and Vascular Institute. Cardiologist William Merhi, DO, FACC, of West Michigan Cardiology and cardiothoracic surgeon John Heiser, MD, of West Michigan Cardiothoracic Surgeons will coordinate the study and perform the cases.

“We’re excited to partner with other leading cardiac specialists in the U.S. to study this technology,” said Merhi. “The boundaries of medical treatment are constantly being expanded and SpectrumHeatlh is proud to be part of this.”

“The trend of developing less invasive ways to treat patients has been evolving for decades,” said Heiser. “If this investigational treatment is effective, we will have the ability to provide a minimally invasive approach for patients who are not candidates for traditional valve surgery. It would advance cardiac care for people in West Michigan.”

The Medtronic CoreValve U.S. Clinical Trial will enroll more than 1,200 patients at 40 U.S. clinical sites, including the Meijer Heart Center. For more information about the Medtronic CoreValve U.S. Clinical Trial, see www.aorticstenosistrial.com.

The Heart & Vascular Institute is currently enrolling patients in the trial. For more information about participating in this clinical trial, contact William Merhi, DO, at 616-456-9553 or John C. Heiser, MD, at 616-459-7258 or email CoreValve@spectrumhealth.org.