UNC Health Talk

UNC enrolling patients in Momentum 3 Clinical Trial

Media Contact: Jamie Williams, jamie.williams@unchealth.unc.edu, 984-974-1149

The HeartMate 3 is an investigational implantable device that helps to circulate blood throughout the body. Occasionally referred to as a “heart pump”, it is designed to supplement the pumping function of the heart in patients whose hearts are too weak to adequately circulate blood on their own. The Thoratec HeartMate II is the most commonly implanted LVAD and has supported well over 20,000 patients with end-stage heart disease but, Jason Katz, MD, said that the HeartMate 3 investigational device has many added features that may help to reduce the risk of complications and improve patient outcomes. The MOMENTUM 3 Clinical Trial is designed to evaluate the performance and safety of the HeartMate 3 at six months of LVAD support in subjects with advanced heart failure.*

Katz, director of Cardiovascular Clinical Trials and medical director, UNC Mechanical Heart Program, said that cardiologists across the UNC Health Care system should consider referring their patients with advanced, left ventricular heart failure for consideration of enrollment in this trial. Patients who would qualify are those who have had frequent hospitalizations and a declining quality of life.

Katz, is one of two principle investigators conducting the trial – along with Brett Sheridan, MD, surgical director of Mechanical Circulatory Support and Transplantation. He added that the novel study design of this trial may allow for greater patient eligibility and enhanced device applicability.

“Historically, studies have separated patients into categories based on whether or not they are transplant eligible. This study includes patients in both categories and we are hopeful that broad eligibility will lead to robust enrollment,” Katz said.

At UNC Hospitals, six study participants have already enrolled in the trial, and enrollment will continue until the 60 participating sites enroll just over 1,000 patients. The device is being evaluated for long-term support for patients who are not candidates for cardiac transplant as well as for short-term support as a bridge to cardiac transplantation.

Katz said several technological advancements make the HeartMate 3 a potentially exciting development for both patients and physicians.

“There are several features of the investigational device researchers hope will work better with the body and the blood [during and after the surgical implantation]. These features may help to reduce risk factors like bleeding and stroke which have plagued the field of mechanical support,” Katz said. The MOMENTUM 3 Clinical Trial will be evaluating the effectiveness and safety of the HeartMate 3 to determine whether these features will reduce the risk of complications and improve patient outcomes as compared to the currently approved model, the HeartMate II.

The results of the first 50 patients participating in a trial in Europe, the HeartMate 3 CE Mark clinical trial, were recently presented at the Heart Failure Society of America National Conference, and, Katz said the results were positive.

To be considered for the MOMENTUM 3 Clinical Trial, patients:

• will have heart failure symptoms that are difficult to manage, even with medical treatment

• are unable to perform physical activity without discomfort

• have noticed a decline in quality of life due to the disease

• have been hospitalized one or more times for heart failure in the past six months

All randomized subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Physicians who would like to refer patients to the clinical trial team should utilize the UNC Center for Heart & Vascular Care’s Open Access Referral System. This one-call referral service can be reached at (866)862-4327. More information is also available here.

For more information regarding the MOMENTUM 3 Clinical Trial visit http://www.thoratec.com/vad-trials-outcomes/ongoing-clinical-trials/hmiii-usa.aspx.

* US: Caution: Investigational Device: Limited by Federal United States law to investigational use.

How HeartMate 3 Works:

The HeartMate 3 LVAS includes a Full MagLev™ centrifugal blood pump and is designed to supplement the pumping ability of the weakened heart’s left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. The device is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta (the main artery that feeds blood into the entire body), leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body. The patient wears an external, wearable controller and battery system that powers the pump. The HeartMate 3 LVAS can pump up to 10 liters of blood per minute.