Project details
Patients from up to 75 experienced clinical sites in Canada, the United States, Europe and Japan will be enrolled in the study. The Libin Cardiovascular Institute of Alberta, University of Calgary, is the Clinical Coordinating Centre and the Montreal Heart Institute is the Data Coordinating Centre . An international executive committee of recognized leaders in arrhythmia clinical trials has designed this study and will oversee the trial. An independent Data and Safety Monitoring Committee will provide additional, independent oversight. To assess feasibility, the study will begin as a pilot at 16 sites in the United States, Canada and Europe. If feasibility is demonstrated (enrollment and site activation), enrollment will expand to all 75 sites in September 2012.

Sudden cardiac arrest is a sudden, abrupt loss of heart function - it is not a heart attack (myocardial infarction), which is caused by a blocked vessel leading to loss of blood supply to a portion of the heart muscle. Instead, most sudden cardiac arrest episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation. These are abnormalities of the heart’s electrical conduction system.

Cardiac arrest is reversible in most victims if it’s treated within minutes, but the only effective treatment is the delivery of an electrical shock, either with an automated external defibrillator, or with a stopwatch-sized implantable defibrillator. Implantable cardioverter-defibrillators (ICDs) have been proven to be 98 percent effective in treating dangerously fast ventricular arrhythmias that can lead to sudden cardiac arrest.

ICDs devices are tiny, battery-powered computers that are implanted under the skin, and connected to the heart via leads. These tiny wires carry signals from the heart to the device, and carry electrical impulses from the device to the heart. The third part of the system is an external computer located in the doctor’s office or clinic that is used to program the device, as well as retrieve information from the device about the patient’s condition and device status that will assist in treating the disorder.

Project Partners

Alberta Advanced Education and Technology
In collaboration with Campus Alberta and Alberta Innovates partners, Advanced Education and Technology strives to build a prosperous province through a dynamic and integrated learning and innovation system built on a foundation of highly skilled people in support of a knowledge-based economy and society in Alberta.

Western Economic Diversification Canada
Western Economic Diversification Canada works with the provinces, industry associations, and communities to promote the development and diversification of the western economy, coordinates federal economic activities in the West and advances the interests of western Canadians in national decision making.

Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Their broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help their customers to deliver better care to more people around the world at a lower cost. In addition, they partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit their website at www.gehealthcare.com

University of Calgary, Faculty of Medicine
UCalgary’s Faculty of Medicine is a national leader in health research with an international reputation for excellence and innovation in health care research, education and delivery. They train the next generation of health practitioners and move new treatments and diagnostic techniques from the laboratory bench to the hospital bedside, improving patient care. For more information visit http://medicine.ucalgary.ca.

Libin Cardiovascular Institute of Alberta
The Libin Cardiovascular Institute of Alberta provides superb education and training of health care professionals, world class treatment, using state-of-the-art technology, increased access to cardiac services through innovative use of technologies such as telehealth, research programs in cardiovascular basic science, biomedical engineering, clinical science, population health research, and the relationships among them.

For over 30 years the institute has been at the forefront of cardiac electrophysiology research, education and care delivery. The envelope of medical science knowledge has been expanded by responding to the gap between basic biomedical science and healthcare innovation by reinforcing translational science including the execution of clinical trials such as those led by Dr. Derek Exner.  For more information, visit www.LibinInstitute.org.

Western Economic Partnership Agreement
The Canada-Alberta Western Economic Partnership Agreement targets joint strategic priorities where Canada and Alberta work together and with other interested stakeholders to help create innovative, entrepreneurial and sustainable communities.

Canada-Alberta Joint WEPA Priorities:

• Technology Commercialization - Create and/or grow the knowledge-based economy in Alberta by commercializing new products, technologies and services into domestic and international markets.
• Business Productivity and Competitiveness - Strengthen small business development, growth and competitiveness in the global economy.
• Trade and Investment - Expand access to international markets and investments.
• Value-Added Processing - Increase revenues of traditional industries by adopting new technologies and processes that transform low value outputs into high value products.

Project Funding (pilot phase)
Total funding for the pilot phase of the project is $16.8 million.  This includes:

• $1 million from the Government of Alberta;
• $788,000 from Western Economic Diversification Canada,;
• $1.5 million from the Libin Cardiovascular Institute of Alberta at the University of Calgary and its donors; and,
• additional support from both GE Healthcare and Medtronic Inc..