— The U.S. Food and Drug Administration said Monday that a $12.8 billion study to study the effects of the implantable “cubital vein” on the blood supply and cardiovascular system of patients with heart disease is moving forward with more than 50 participants.
The study will examine the effects on blood pressure, cholesterol, blood flow and blood clotting in people who have heart disease and healthy controls.
The study, led by the Johns Hopkins University School of Medicine, will be conducted over the next few years, said Sarah Kost, chief medical officer at the agency.
“It’s an important step forward,” Kost said at a news conference.
We’re still in the early stages of the study, but the study is moving along in phases.
“The implants were developed in the 1960s and are inserted into the heart via an artificial valve.
The veins are connected to a large artificial valve that pumps the blood back into the body.
Some studies have shown the implants may prevent heart attacks in people with existing heart disease, but they have not been linked to long-term results.
The FDA is seeking more than 2,000 participants in the study.
The agency said the study will include more than 5,000 people.
Participants in the studies will be followed for about four years and receive monthly blood tests to monitor for any side effects.
Participators will be offered a blood thinning pill to prevent bleeding.
Participating patients will receive about 20 implants to help reduce the chance of bleeding.
About 50 of the devices have been implanted in more than 100,000 adults over the past four years, and more than 30 have been given to patients with congestive heart failure.
At the news conference, FDA officials said the goal is to see if the implants will lower blood pressure and cholesterol levels in people without heart disease.
People in the trial will be given the implant for a maximum of about four to six months.
An initial study will be published in 2018 and the full study will follow people until 2036.
More than 10,000 more people will be randomly assigned to the implant study and receive a second study starting in 2021.
In 2018, the FDA also approved the development of a device that blocks a type of drug that affects the blood vessels in the heart, called mitral valve disease.
The device is being used in the U.K. and Canada and will be made by Roche of Quebec.
The devices have a similar shape and are made of titanium.