Congestive Heart Failure Patients May Be Eligible For Treatment to Help Them Live Longer

Patients diagnosed with moderate aortic stenosis and congestive heart failure may qualify to participate in a clinical trial that will determine whether a minimally-invasive valve replacement benefits those who are currently treated only with medication.

The procedure, known by the acronym “TAVR” (Transcatheter Aortic Valve Replacement), is currently only approved for use in patients with severe aortic stenosis. In those cases, the aortic valve is replaced through a transcatheter process that replaces open-heart surgery and has resulted in individuals feeling better, avoiding hospital stays, and living longer.

To date, TAVR hasn’t been approved as an option for those with moderate aortic stenosis. Those patients currently receive medical therapy and are observed on guideline directed medical treatment until their condition worsens. The national ‘TAVR UNLOAD’ trial Memorial Cardiac and Vascular Institute is participating in seeks to determine whether performing the valve replacement much earlier, before the patient’s condition becomes severe, delivers the same benefits.

“The exciting part to the patient participating in the TAVR trial is potentially having access to a treatment that otherwise wouldn’t be available to them,” said Jonathan Roberts, MD, medical director of Clinical Research and Education, Interventional Cardiology for Memorial Healthcare System and program director of its Cardiology Fellowship program. “TAVR is an amazing procedure that we perform quite frequently, but it’s new for us to be doing this on those whose disease hasn’t progressed to its later stages.”

The clinical trial will randomize patients with moderate aortic stenosis, with 50% of them receiving the TAVR procedure and the other half continuing with traditional medical therapy. Researchers expect the five-year comparison study to produce results that demonstrate whether those who have the procedure earlier get the same benefit as those who undergo TAVR once their heart disease becomes more severe and how those results compare with those who continued with guideline directed medical therapy. “Memorial’s participation in the trial is a direct result of the healthcare system’s ascension as an academic medical center with the expertise and patient volumes required of host facilities,” said Dr. Roberts.

Those who have been diagnosed with congestive heart failure and moderate aortic stenosis may be eligible to participate in the TAVR UNLOAD trial, which is currently accepting candidates that meet specific medical criteria. To learn more about eligibility, contact Memorial’s Office of Human Research at 954-265-1847.