News | March 16, 2010

International Study of Transcatheter Aortic Valve System Launched

March 16, 2010 — Several new initiatives in a robust international clinical program for a transcatheter aortic valve system have been set in motion with the goal of expanding the evidence base for the future of structural heart disease therapy.

Medtronic Inc. launched the study for its CoreValve transcatheter aortic valve system, a minimally invasive alternative to open-heart surgery for aortic valve replacement.

The CoreValve Advance clinical study began enrolling patients last week, with the first two implants occurring in Germany. CoreValve Advance is a prospective, observational international post-market study to evaluate clinical outcomes of patients with severe aortic stenosis who are treated with the CoreValve system in standard clinical practice. The CoreValve system received CE mark in March 2007. It is not yet available in the United States for commercial sale or clinical use.

“The CoreValve Advance study is Medtronic’s first major clinical evaluation of the CoreValve system since we acquired it in April 2009,” said John Liddicoat, M.D., cardiac surgeon, vice president and general manager of the structural heart division, part of the CardioVascular business, at Medtronic. “It is one of several CoreValve studies planned to begin this year worldwide as part of a rigorous, long-term clinical program.”

Approximately 1,000 patients with severe aortic stenosis will be enrolled in CoreValve Advance at up to 90 clinical trial sites in countries where the CoreValve system is commercially available. Most of the trial sites will be in Europe, where the CoreValve system is used in approximately 75 percent of transcatheter aortic valve replacements involving percutaneous femoral access.

The principal and co-principal investigators of CoreValve Advance are professor Axel Linke, Universität Leipzig Herzzentrum, and professor Robert Bauernschmitt, Deutches Herzzentrum München, both in Germany. The first study procedures were performed by professor Horst Sievert, CardioVascular Center Frankfurt, also in Germany.

“We have been very pleased with past clinical results using the CoreValve system, and we anticipate great scientific value for future patients by participating in the CoreValve Advance study,” said professor Sievert. “The resulting data will provide important information to physicians and regulatory officials worldwide related to broad-scale safety and device performance for patients with severe aortic stenosis who often are at high risk for open-heart surgery.”

Study patients will be followed for at least five years following implantation of CoreValve. The primary endpoint is major adverse cardiac and cerebrovascular events (MACCE) at 30 days following the procedure, with MACCE defined as a composite of: all-cause mortality; myocardial infarction; emergent cardiac surgery or percutaneous reintervention; and stroke. The study also includes 19 secondary endpoints and data collection related to the health economic impact of CoreValve on patient quality of life and therapy cost-effectiveness.

The CoreValve system is designed to enable replacement of a diseased aortic valve without open-heart surgery or surgical removal of the native valve. Typically delivered through the femoral artery, it has been implanted in more than 7,500 patients worldwide and is now available in 29 countries outside the United States.

For more information:

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init