News | January 02, 2014

Medtronic Randomizes First Patients in Symplicity HTN-4

Clinical trial could expand access to Symplicity renal denervation system

medtronic symplicity renal denervation therapy hypertension cath lab trial study
January 2, 2014 — Medtronic Inc. announced that the first patients were randomized in Symplicity HTN-4, which will evaluate the Symplicity renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure greater than or equal to 140 and less than 160 mm Hg, despite treatment with three or more anti-hypertensive medications of different classes). Symplicity HTN-4, which randomized its first patients at Medical University of South Carolina (MUSC), Piedmont Heart Institute and Duke University Medical Center, builds upon Symplicity HTN-3, the only other renal denervation clinical trial in the United States. In the United States, the Symplicity renal denervation system is available for investigational use only.
 
Symplicity HTN-4 will enroll up to 580 patients at approximately 100 sites, continuing to target a patient population in line with the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-7), the American Heart Association (AHA) and the European Society of Hypertension's definition of uncontrolled hypertension. Similar to the U.S. trial, Symplicity HTN-3 study evaluating patients with uncontrolled hypertension with a systolic blood pressure greater than or equal to 160 mm Hg, the Symplicity HTN-4 study will be blinded and include a sham control.
 
Principal investigators of Symplicity HTN-4 are David Kandzari, M.D., director and chief scientific officer, Interventional Cardiology and Interventional Cardiology Research, Piedmont Heart Institute, Atlanta, and Michael Weber, M.D., professor of medicine, Division of Cardiovascular Medicine, SUNY Downstate College of Medicine, Brooklyn, New York City.
 
For more information: www.symplifybptrial.com, www.medtronicrdn.com

Related Content

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
Overlay Init