Medtronic has completed enroling first patient in its Improve Brady study, designed to provide evidence-based guidelines and recommended therapies for patients with sinus node dysfunction.
The multi-centre, prospective trial will involve up to 14,850 patients in nine countries including Argentina, Bangladesh, China, Hungary, India, Mexico, Peru, Russia and Uruguay.
The trial, which will be conducted in two phases, includes a phase I study in which physicians will assess and treat patients as per their institution's standard care practice.
In the second phase, study investigators will participate in an educational workshop where they will use a toolkit including diagnostic algorithms, informational videos and resources to educate patients about sinus node dysfunction as well as to process improvements within their respective practices.
After implementation of the toolkit, data from the two phases will be compared to demonstrate the influence of process improvement measures on patient care, according to the company.
University of Oklahoma College of Medicine cardiovascular section professor and chief Dr Dwight Reynolds said previous studies showed physicians can be successful in accelerating guideline-based care among patients in a real-world setting.
"It is our hope that this large-scale, global study will show that education and other initiatives can improve diagnosis, use of appropriate therapies and the overall quality of life for these patients who previously have been underserved," Reynolds said.
Medtronic senior vice president and cardiac rhythm disease management business president Pat Mackin said the company is focused on improving patient care and providing access to clinically-validated medical solutions in emerging markets.
"Through educational initiatives that advocate for evidence-based therapies, we hope to encourage worldwide adoption of consensus treatment guidelines - such as those developed and supported by the top cardiovascular physician societies in the world - to provide the best quality of care to all patients with heart rhythm disorders," Mackin said.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.