US-based Medtronic has enrolled the first patients in the Improve SCA Clinical Study, a first-of-its-kind study designed to better identify those at major risk of sudden cardiac arrest (SCA) in developing countries.
The first patients were enrolled at West China Hospital and Fuwai Hospital in China.
Patients will either be indicated for an implantable cardioverter defibrillator (ICD) or a cardiac resynchronisation therapy defibrillator (CRT-D).
West China Hospital in Chengdu City, Sichuan Province, China, Dr Dejia Huang said: "The study will provide the clinical evidence needed to help primary prevention patients at the highest risk of SCA access the therapy they need, and has the potential to eventually influence local guidelines."
The Improve SCA Clinical study will enroll up to 4,800 participants and follow them for two years, with a focus on more than 15 countries across Central and Eastern Europe, Asia, the Middle East, Africa and Latin America.
It will be a prospective, non-randomised, multicentre study that assesses patients meeting current class I guidelines for ICD or CRT-D implants as defined by the American College of Cardiology, American Heart Association and other major medical associations.
The aim of the study is to find better ways to screen patients in these markets who are at high-risk for SCA but have not had a previous life-threatening arrhythmia.
Medtronic vice-president and general manager of the tachycardia business Dr Marshall Stanton said: "While leveraging our global expertise, we work to identify challenges at the local level and become part of a long-term solution.
"Improve SCA is our latest study that aims to help even more patients access the most innovative, life-saving therapies available today."
Once completed, the study may help clinicians identify and refer primary prevention patients for ICD/CRT-D therapy, and help more patients make informed decisions about receiving a defibrillator.
Image: Medtronic world headquarters, Minneapolis, Minnesota, US. Photo: courtesy of Medtronic, Inc.