Percutaneous Valvular Interventions Clinical Trials

Cedars-Sinai's Heart Institute is a global leader in seeking nonsurgical solutions for some of the most common heart conditions: malfunctioning heart valves. Physicians at the Heart Institute, in conducting multiple clinical trials, have performed more of these minimally invasive valve procedures than doctors at any other U.S. medical center.

Until just recently, open heart surgery was the only option for patients diagnosed with heart disease who needed treatment for a failing heart valve and Cedars-Sinai has a long history of innovation in this area.

While open-heart surgery continues to be the most effective treatment for many, physicians in Cedars-Sinai Heart Institute's Cardiac Catheterization Laboratory, led by Raj Makkar, MD, are at the fore in clinical trials of minimally invasive procedures to replace patients' aging and malfunctioning aortic, pulmonic and mitral valves.

In the nonsurgical procedures they are testing, the new valve or repair device is delivered to the patient's heart via catheter through an artery, typically beginning in the groin.

"Just as there has been a technology explosion with cell phones and laptop computers, there has been a surge in new medical technology that allows us to do more and more in the Catheterization Lab," said Makkar, an associate director of the Heart Institute and the Stephen R. Corday, MD, Chair in Interventional Cardiology. "Today, one of the exciting new directions in interventional cardiology is minimally invasive treatment of heart valves using catheter techniques."

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A Global Leader in Clinical Trials on Nonsurgical Heart Valve Care
Procedure animation courtesy of Edwards Lifesciences

Several clinical trials of nonsurgical heart valve procedures have shown comparable favorable outcome rates and shorter recovery times than traditional open-heart surgery. One-year results published in the New England Journal of Medicine showed that patients who underwent the non-surgical aortic valve replacement were less likely to need to go back to the hospital, or to experience the weakness and dizziness associated with aortic stenosis, although they did show a higher incidence of stroke, vascular complications, and bleeding.

Open-heart surgery to repair or replace heart valves is still the "gold standard," says Eduardo Marbán, MD, director of the Cedars-Sinai Heart Institute and the Mark S. Siegel Family Professor, who adds that demand for percutaneous procedures is growing.

"The heart's valves wear out as you age," Marbán said. "And the older you are generally makes you a less attractive candidate for open heart surgery. This option will become more and more important to patients as the Baby Boom Generation ages."

Disease affecting the aortic valve can pose serious health issues, now more visible than ever with high-tech imaging techniques. In clinical trials, Cedars-Sinai physicians are working with specialized makers on the nonsurgical ways to fix or replace this valve in specific patient populations. 

Similar research is under way on the pulmonic valve, which many may be familiar with because physicians have developed ways to treat it in "blue babies," those with congenital pulmonary stenosis.

Cedars-Sinai has long been a leader in developing minimally invasive therapies for the mitral valve.

While patients needing mitral valve repair can opt for minimally invasive surgeries, those requiring aortic or pulmonic valve replacement will need to consult Heart Institute physicians to determine if they qualify to participate in a clinical trial.

Patients enrolled in clinical trials for minimally invasive valve procedures generally are deemed too ill to undergo open heart surgery, though there are plans for new studies that call for enrolling patients less frail. Some patients who have received a new aortic valve in clinical trials, thus far, have sat up within hours after the procedure; many have been sent home within a few days.

Contact information regarding these heart valve clinical trials can be found here or by contacting the research coordinators listed below.

  • Mitral valve - Simmy Shirazi (310) 248-6673 or Diana Remba (310) 423-6586
  • Aortic valve - Mitch Gheorghiu (310) 423-6152
  • Pulmonic valve - Mitch Gheorghiu (310) 423-6152