Research and Clinical Trials USA
Research and Clinical Trials USA
Innovative Hypertension Study
The University of Miami Miller School of Medicine is pleased to announce its participation in the SYMPLICITY HTN-3 study, a clinical trial of the investigational Medtronic Symplicity® renal denervation system for treatment-resistant hypertension. Dr. Eduardo de Marchena, interventional cardiologist and associate dean for international medicine, is the principal investigator. The study, which will enroll approximately 530 patients, will assess the safety and effectiveness of renal denervation with the Symplicity renal denervation system.
Renal denervation is a minimally invasive, catheter-based procedure; it uses a tiny device that is threaded into the arteries to deactivate the nerves to the kidneys. The Symplicity renal denervation system has been successfully used since 2007 to treat more than 2000 patients worldwide. It has been commercially available in Europe and Australia since April 2010. The Symplicity renal denervation system is not approved by the US Food and Drug Administration (FDA) for commercial distribution in the United States.
For more information, please contact research director, Dr. Christian Marin y Kall via email at IMIinfo@med.miami.edu
Aortic Valve Replacement Trial
Dr. Eduardo de Marchena, interventional cardiologist and associate dean for international medicine and Dr. Tomas Salerno, professor of surgery and vice chairman of faculty development for the DeWitt Department of Surgery, are the principal investigators of the Medtronic CoreValve® U.S. Trial.
Dr. de Marchena spearheaded the first certified CoreValve® replacement program in South America in 2008. The CoreValve® is a great alternative to high-risk and extreme high-risk patients who are not candidates for open heart surgery and for whom conventional aortic valve replacements are not prudent.
For more information, please contact research director, Dr. Christian Marin y Kall via email at IMIinfo@med.miami.edu
Migraine Trial
Dr. Eduardo de Marchena, interventional cardiologist and Dr. Gustavo Ortiz, assistant professor of clinical neurology, are co-principal investigators of the Premium Clinical Migraine Trial.
The objective of this trial is to evaluate whether percutaneous patent foramen ovale (PFO) closure is effective in reducing the incidence of disabling migraine headaches in patients who are refractory to medical management. This will be evaluated by investigating whether patients with PFO closure experience significant reduction in migraine headaches through a twelve-month post PFO closure period in comparison to a sham group. Patients 18-65 years of age with migraine (with or without aura) may qualify for the study.
For details, please visit www.premiumtrial.com
For more information, please contact:
Dr. Christian Marin y Kall via email at: IMIinfo@med.miami.edu or call 305-243-5535
Maria Lichtenberger via email at: mlichtenberger@med.miami.edu or call 305-243-1386
For other departments at the University of Miami Miller School of Medicine currently conducting clinical and translational science research, please click here.
To reach the International Medicine Institute, please call or email us at:
305-243-9200
IMIinfo@med.miami.edu