As one of the largest heart failure centers in the U.S., Nebraska Medicine is participating in a nationwide clinical research trial of an investigational LVAD called HeartMate 3.
For patients with advanced congestive heart failure, the heart is weak and unable to keep adequate blood circulating in the body, resulting in symptoms such as fatigue, shortness of breath and weight gain.
If that describes you, or someone in your family, you know that medications can help. A heart transplant is another possibility. Also, a Left Ventricular Assist Device (LVAD) can assist the heart, either long-term, or until a heart is available for transplantation.
As one of the largest heart failure centers in the U.S., Nebraska Medicine, is participating in a nationwide clinical research trial of an investigational LVAD called HeartMate 3, IRB#344-15-FB.
Nebraska Medicine began enrolling patients in July 2015, and is still enrolling patients. Nationwide, 59 hospitals are participating in this trial – and will enroll 1,028 patients total, who will be followed for up to two years.
Details about the device
The first LVAD device was developed originally in the 1980s. The device circulates blood throughout the body when the heart is too weak to pump blood on its own. It is sometimes called a “heart pump” or “VAD.”
HeartMate II® is the second version of this device — a smaller version of the LVAD that is implanted in the chest, and has been a real breakthrough in medical technology. This device has rapidly become the most widely used device of its kind in the world.
The HeartMate 3 is the newest generation of LVAD – designed to work at slower speeds and hopefully prevent blood cell breakage. The MOMENTUM 3 trial is designed to evaluate the safety and effectiveness of the HeartMate 3 by determining whether the HeartMate 3 has similar outcomes to what we have seen with the HeartMate II. While the HeartMate 3 was designed in an attempt to negate some of the side effects that are seen with the HeartMate II, this is not the primary intent of the trial; however, it is something that will be evaluated.
The design of the Heartmate 3 pump will theoretically allow the pump to “wash itself out,” potentially reducing the risk of clot formation within the pump. Also, because the pump is designed to prevent blood cell breakage, it is theorized that the patient may have a lower risk of complications of blood cell breakage.
Nebraska Medicine is very excited about participating in the MOMENTUM 3 trial and expects that all patients will be enrolled nationwide by this summer.
Who participates in the trial?
Patients with severe congestive heart failure, who are either candidates for heart transplantation or need the device for long-term therapy, may be eligible for the research study.
In this research study, eligible patients will receive either a HeartMate 3 or HeartMate II pump. The research study team will monitor participants’ quality of life, heart function, device function, need for hospitalization or another surgery – as well as survival and other factors. Collecting outcomes data such as this will help assess the device’s safety and effectiveness.
Results of this research study are not expected to be released until enrollment is complete and all the data is collected and submitted to the U.S. Food and Drug Administration (FDA). Certainly, the HeartMate II has been a great success – so we are excited to see what the data from the MOMENTUM 3 trial will show.
Is it time to speak with a cardiologist about your heart disease risks? To make an appointment with one of our advanced heart failure specialists, please call 1-800-922-0000.