The MOMENTUM 3 U.S. IDE Clinical Trial
MOMENTUM 3 Overview
The MOMENTUM 3 U.S. IDE Clinical Trial is a prospective, multi-center, unblinded randomized study comparing the HeartMate 3 LVAS to the HeartMate II® LVAS in advanced stage heart failure patients. The study is being conducted as a staged pivotal study that includes a pre-specified early assessment for safety (completed in April 2015). The study is enrolling more than 1,000 participants. Researchers at up to 60 centers are evaluating the device for use as long-term support for patients who are not candidates for cardiac transplantation (also known as Destination Therapy). It is also being evaluated for short-term support options, for patients awaiting transplantation (Bridge-to-Transplantation).
The HeartMate 3 Left Ventricular Assist System (LVAS) is an investigational chronic mechanical circulatory support (MCS) device intended for a broad range of advanced heart failure patients. HeartMate 3 is designed to restore blood flow while improving survival, functional status and quality of life.*
- Blood compatibility. The design of the HeartMate 3 includes large blood flow gaps designed to reduce blood trauma.
- Full MagLev™ (magnetically-levitated) flow technology allows the device's rotor to be suspended by magnetic forces. There is no friction and therefore less wear and tear on the rotor. This contact-free environment is designed to help minimize complications.
- Artificial Pulse technology may impact a reduction in clinical adverse events. The artificial pulse may also assist with pump washing with the goal of reducing the possibility of blood clotting, which can lead to thrombus formation.
- Textured Blood-Contacting Surfaces. Encourages a tissue-to-blood interface that potentially reduces complications. Like inside the heart, blood is in contact with tissue and not an artificial material.
- Advanced design for surgical ease. HeartMate 3 incorporates advanced technology to enhance the surgical experience, including an engineered attachment designed to allow for ease of implantation.
- Designed for an Active Lifestyle. The Pocket Controller™ provides a small, safe, smart patient interface for the HeartMate 3 LVAS. It features single-sided cables, so it discreetly slips into a front pocket for easier manageability.
How It Works
The HeartMate 3 LVAS includes a fully magnetically levitated 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.
Primary Study Objective
To evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.
Advanced Heart Failure New York Heart Association (NYHA) Class III patients with dyspnea upon mild physical activity, or NYHA Class IV who are refractory to advanced heart failure management.
The indications for each intended use are as follows:
- Short-Term Indication (i.e., Bridge to Transplant): Composite of survival to transplant, recovery or six months of LVAD support free of debilitating stroke (modified Rankin Scale >3) or reoperation to replace the pump.
- Long-Term Indication (i.e., Destination Therapy): Composite of survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (modified Rankin Scale > 3) or reoperation to replace the pump.
Secondary Study Endpoints
The following secondary objectives are being evaluated:
- Quality of Life measured by the EuroQol-5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Functional status as measured by the Six Minute Walk Test (6MWT) and New York Heart Association (NYHA) classification
- Frequency and incidence of all re-operations
- Frequency and incidence of all rehospitalizations
- Frequency, incidence and rates of pre-defined anticipated adverse events
- Frequency and incidence of device malfunctions
All randomized subjects are being followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
To learn more or to find a hospital participating in the HeartMate 3 trial go to: https://clinicaltrials.gov/ct2/show/NCT02224755?term=heartmate+III&rank=1. ClinicalTrials.gov Identifier: NCT02224755
* US: Caution: Investigational Device: Limited by Federal United States law to investigational use.