A potentially groundbreaking study of a new implantable device to help curb high blood pressure is taking place across the country, and Northwell Health is one of 30 screening centers seeking participants.
Dr. Andrew Galmer, investigator on the study and vascular medicine specialist in Northwell’s Department of Cardiology, said teams from Northwell’s Sandra Atlas Bass Heart Hospital at North Shore University Hospital and the Feinstein Institute for Medical Research, both in Manhasset, are the first in New York to treat a patient with the ROX Coupler and are the only participating institutions in the northeast.
The study will also be conducted at Lenox Hill Hospital in Manhattan.
The ROX Coupler, Galmer said, creates a passage between an artery and a vein in the pelvis, redirecting measured amounts of arterial blood to the vein and lowering blood pressure.
The device has been studied in Europe before the nationwide trial and has been shown to reduce blood pressure by about 30 millimeters of mercury in comparison to the average 5 to 10 millimeters reduced in other treatments, such as medication.
Galmer and his colleagues are part of a large, multi-center trial that will include up to 30 study sites in the United States, and he said the ROX Coupler could revolutionize therapies for high blood pressure patients.
“We are thrilled to offer patients the opportunity to participate in this new trial because the device we are studying has been shown to decrease blood pressure significantly more than other devices that have been studied in hypertension,” Galmer said. “In my opinion, the ROX Coupler is the most intriguing new device being studied in the field of hypertension.”
So far, Galmer said about 10 patients have been enrolled in the study following three screenings. Once enrolled, patients will be monitored for up to one year.
“Hypertension is one of these things where so many people have it,” Galmer said. “It’s one of these things that people don’t feel, and it puts people at risk for heart attack and stroke. Many patients we’re seeing, despite tacking on more and more medications, they’re walking around with blood pressure above the recommended limit.”
Those who are interested who are between the ages of 22 to 85, are on at least three blood pressure control medications and would like to learn more about the trial, contact research assistant Theresa Yirerong at (516) 562-2653 or TYirerong@northwell.edu.