Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 VAD
PumpKIN Study Basics
The PumpKIN Clinical Trial is a study for children whose hearts have trouble pumping blood to the rest of their body, a condition known as heart failure. When this happens, a Ventricular Assist Device, or VAD, may be used. A VAD is a mechanical pump that supports heart function and blood flow in people who have weakened hearts. This study is designed to find out which device, the Jarvik 2015 VAD (Jarvik) or the EXCOR® VAD (EXCOR®) works better for infants and small children. The Jarvik is investigational and has only been tested in animals. It is approved for testing in humans by the United States Food and Drug Administration (FDA). The EXCOR® is approved by the FDA. Please see the Study Design page
for more information on the differences between the Jarvik and the EXCOR®.
Who will be in the study?
The children eligible for the study have hearts that have trouble pumping blood to the rest of their body and their doctors have decided a VAD may help improve blood circulation. There are other more specific criteria that can be reviewed on the clinicaltrials.gov website, which you can find by clicking here
What will happen in the study?
If your child is eligible, the study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study. The study has four major parts:
Screening: We will review and record information from your child’s medical record to get background information about his or her heart problem, how the condition was treated, and any other medical problems your child has. We will also do a physical examination that includes measurements of body length, weight, pulse, blood pressure, temperature, and head circumference. We will also take blood samples for laboratory tests. This information will be reviewed by your child’s study doctor to confirm that your child is eligible for the study.
Randomization: Your child will be randomly assigned to receive either the Jarvik or the EXCOR®. The assignment is done by chance, like flipping a coin. About half of the patients in this study will be assigned to receive the Jarvik and the other half will be assigned to receive the EXCOR®.
Surgery: The study VAD will be placed during heart surgery in the operating room. Before the surgery, your child will receive medication to help him or her relax, and anesthesia medications. A breathing tube will be placed in your child’s windpipe to help your child’s lungs receive oxygen from a breathing machine called a ventilator. During surgery, the doctors will open your child’s chest and use a heart-lung machine to circulate blood and oxygen through the body while the surgeon is working on the heart. After the surgery, your child will be monitored closely in the Intensive Care Unit.
- If your child is getting the Jarvik, doctors will place the pump directly into the heart. The pump will be held in place with stitches. There will be a few tubes/wires outside the body.
- If your child is getting the EXCOR®, tubes will be attached to the left side of your child’s heart and blood vessels with stitches. Once the tubes are secure, the surgeon will connect the tubes to the blood pump. The pump will be located outside your child’s body.
Follow up: Your child will be closely monitored while the pump is in place. During this time, the study team will assess how well your child is doing through physical exams, laboratory tests, medical support, questionnaires, and other tests, up until right before the pump is removed. The study doctors will also follow your child after the pump is removed.
How long will we be in the study?
Your child’s participation in this study can last up to 18 months, depending on how long he or she is on the study VAD. The final study visit will be one year after the pump is removed.
What are the possible benefits to being in this study?
Your child may not receive any benefits from being in this study.
Your child’s medical condition may improve while using either the Jarvik pump or the EXCOR® pump.
If your child is assigned to receive the EXCOR® pump, the benefits include having your child receive a currently FDA approved pump that has been used successfully in several hundred children.
If your child is assigned to receive the Jarvik pump, the benefits may include fewer complications related to your child’s heart condition or to use of the pump compared to currently available devices; and increased physical activity and quality of life while on the pump, due to the smaller size of the Jarvik.
What are the possible risks to being in this study?
Taking part in a research study involves risks, or side effects. You should discuss these risks with your child’s study doctor. Children in this study all have a serious heart condition that includes risks that are not related to participation in this study.
The risks of the Jarvik and the EXCOR® include bleeding, stroke, infection, failure of other organs, or death. A complete list of the risks are in the informed consent form and will be explained in full by the study doctor. There may be additional risks that are not yet known. If any new risks are identified, the study doctor will share those with you.
How will patient safety be monitored?
Throughout the study, your child’s health and safety will be monitored by the study doctor. Additionally, an independent board of biomedical scientists and medical professionals with expertise in areas such as pediatric heart failure and VADs will regularly review study data and make recommendations to the NHLBI regarding patient safety in this trial. Stringent safety reporting to the FDA and Health Canada is also required for this trial.