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Clinical-Trial of Symplicity® Renal Denervation System Accepting Patients at Deborah
Deborah Heart and Lung Center announced that it is now enrolling patients to participate in the SYMPLICITY HTN-3 study, a clinical trial of the investigational Symplicity® renal denervation system for treatment-resistant hypertension.
Treatment-resistant hypertension, defined as systolic blood pressure that remains high (greater than 160 mmHg) despite treatment with three or more antihypertensive medications at maximum tolerated doses, poses a serious health threat to nearly six million Americans and 100 million people worldwide. Treatment-resistant hypertension has an associated risk of cardiovascular disease, including stroke and heart attack, as well as heart failure and kidney disease. According to statistics released by Medtronic (the SYMPLICITY HTN-3 research sponsor), 28 percent of hypertensive individuals on medical therapy are considered resistant to treatment.
Renal denervation is a minimally-invasive, catheter-based procedure that disrupts and ablates the nerves that line the walls of the arteries leading to and from the kidneys. These nerves are part of the sympathetic nervous system, which is one of the pathways by which the body controls blood pressure. In people with resistant hypertension, the renal nerves could be hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage. The Symplicity renal denervation system consists of a flexible catheter and proprietary generator.
The Symplicity® catheter is introduced through a guiding catheter placed through puncture into the femoral artery, located at about the level of the groin crease, and is then threaded up into the renal artery leading to each kidney. It is connected to the Symplicity® generator, which produces controlled low-power radio-frequency (RF) energy.
Once in place within the renal artery, the tip of the Symplicity catheter is placed against the arterial wall in several places where it uses controlled, low-power RF energy to ablate or “burn out” the renal nerves according to a proprietary, generator-controlled algorithm. The treatment does not involve a permanent implant and is performed under conscious sedation.
The Symplicity renal denervation system has been used outside of the United States since 2007 to treat more than 4,000 patients worldwide. The Symplicity renal denervation system is currently available in parts of Europe, Asia, Africa, Australia and the Americas; the device is not yet approved by the U.S. Food and Drug Administration (FDA) for commercial distribution in the United States.
Richard Kovach, M.D., Deborah’s Chair of Interventional Cardiology and Endovascular Medicine, Co-Principal Investigator of SYMPLICITY stated: “Renal denervation and ongoing treatment with antihypertensive medications has the potential to help patients with this challenging form of hypertension achieve their target blood pressure levels.”
“We’re excited to participate in the SYMPLICITY HTN-3 study of this investigational interventional treatment, which may represent a new and innovative approach to treating the growing number of treatment-resistant hypertension patients in the United States,” said David Hsi, M.D., Deborah’s Chair of Cardiology, and Co-Principal Investigator in the study.
SYMPLICITY HTN-3 is a randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the investigational Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg. The study will enroll treatment-resistant hypertension patients across several U.S. medical centers. People receiving the investigational treatment will be compared with a control group that does not receive the treatment, with all patients continuing to take their blood pressure medications. Patients enrolled in the SYMPLICITY HTN-3 trial will be randomly assigned to either a treatment group or a control or placebo group. “This study opens an exciting new research avenue for patients with treatment-resistant hypertension,” said Jon C. George, M.D., Deborah’s Medical Director of Clinical Research.
“This is a very important clinical study.” For more information about the trial visit www.SymplifyBPtrial.com or contact Linda Dewey, RN, MSN, CCRC, Senior Study Coordinator 609-893-1200 ext. 5023; or DeweyL@Deborah.org. Potential trial participants include those diagnosed with hypertension (high blood pressure) and unable to control their hypertension even when compliant with three or more blood pressure medications, including a diuretic (water pill), and at maximum tolerated dosage.
CAUTION: Investigational device. Limited by federal (U.S.) law to investigational use.