The multi-center, prospective trial, which will be demonstrated up to 14,850 patients in nine countries, will be conducted in two phases includinga phase I study in which physicians will assess and treat patients as per their institution’s standard care practice.
In second phase, study investigators will participate in an educational workshop where they use toolkit including diagnostic algorithms, informational videos and resources to educate patients about sinus node dysfunction and to process improvements within their respective practices.
The company said after completion of implementing the toolkit, data from two phases will be compared to demonstrate the influence of process improvement measures on patient care.
University of Oklahoma College of Medicine cardiovascular section professor and chief Dwight Reynolds said previous studies have shown that 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 added.
