Research and Clinical Trials USA

Clinical Research

Trans Catheter Aortic Valve Replacement (TAVR/TAVI) – alternate approach to open heart surgery.

The aortic valve is a key heart valve that control the flow of blood into and out of the heart. The aortic valve lets oxygen-containing blood to be pumped out of the heart, from the main pumping chamber of the heart (left ventricle) into the main artery (aorta) delivering blood to the body. If the valve becomes abnormally narrow due to thickening and stiffening (aortic stenosis), the heart must work harder to pump the same amount of blood with each beat. As the heart works harder, the heart muscle thickens (hypertrophy), and the heart chamber (ventricle) may become larger (dilate). Open-heart surgery to replace the diseased aortic valve is the standard treatment.

For some patients, the risk of experiencing major complications during open-heart surgery is very high. These patients are considered at extreme risk to have an operation. The standard treatment for extreme risk patients with symptoms of severe aortic stenosis is medical management. As an alternative to medical management, the Medtronic CoreValve® System has been developed to replace a diseased aortic heart valve without the need for open heart surgery. This system allows the percutaneous aortic valve (study valve) to be implanted (inserted) through a long, thin flexible tube that is inserted through an incision in the skin and threaded through the bloodstream (percutaneous).

Qualified patients will receive a Transcatheter Aortic Valve (TAVI) with the Medtronic CoreValve System (MCS). The procedure can be a less invasive procedure option than open heart surgery. The CoreValve® aortic heart valve is made of natural tissue obtained from the heart of a pig. The leaflets that control the flow of blood in the CoreValve® heart valve are secured to a flexible,self-expanding frame for support.

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 at University of Miami.

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.

Contact us:
For more information, please contact research director, Dr. Christian Marin y Kall via email at IMIinfo@med.miami.edu
or study coordinators: Ximena Marincic-Sanchez, CCRP via email XMarincic@med.miami.edu ;phone: 305.243.0256

Recent news articles on CoreValve® procedures performed at the University of Miami.

1. “Senior gets new lease on life!”
2. Jewish Journal Saves a Life!
3. New Valve Improves Patient’s Heart Just in Time for Anniversary!"!"

Ongoing CoreValve® trials at University of Miami:

1. Continued Access:
2. SURTAVI:
3. Expanded use:

COREVALVE study website

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

Innovative Hypertension Study [ENROLLMENT CLOSED]

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.

UPDATE May 2012, the SYMPLICITY HTN-3 reached the national enrollment limit of 530 patients thus ending the study. We will update the website as soon as we are aware of further details. Thank you

For more information, please contact research director, Dr. Christian Marin y Kall via email at IMIinfo@med.miami.edu

Miami Herald article on renal denervation:
http://www.miamiherald.com/2013/02/24/3251404/um-baptist-clinical-trial-exploring.html
Simplicity- Innovative Hypertension website