IMPROVE Brady Study Aims to Improve Adoption of Treatment Guidelines in Emerging Markets

MINNEAPOLIS –  Medtronic, Inc. today announced the first patient enrollment in the IMPROVE Brady (Registry to Improve the Adoption of Consensus Treatment Guidelines) clinical trial, which will evaluate the impact of physician-led improvement initiatives on the diagnosis and treatment of patients with a common abnormal heart rhythm (sinus node dysfunction). During the study, physicians will use evidence-based guidelines and recommended therapies to treat underserved populations through standardized healthcare processes and patient education. The prospective, multi-center study will analyze up to 14,850 patients in nine countries, including India, Bangladesh, Mexico, Peru, Argentina, Uruguay, Russia, Hungary and China.

Sinus node dysfunction is a condition in which a patient has an abnormal heartbeat or arrhythmia resulting from a malfunction of the sinus node, which is known as the “natural pacemaker of the heart.” Particularly daunting in countries with underserved populations, sinus node dysfunction may lead to bradycardia, a serious heart rhythm disorder whereby the heart beats abnormally slow. Patients with sinus node dysfunction may experience fatigue, syncope (fainting) and/or death or disability related to syncope.

“Previous studies have shown that physicians can be very 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,” said Dwight Reynolds, M.D., professor and chief of the Cardiovascular Section at the University of Oklahoma College of Medicine, Oklahoma City.

Approximately 10 hospitals in each of the emerging market countries will participate in the trial, which will be conducted in two phases. In phase I, physicians will assess and treat patients per their institution’s standard care practice. Information will be collected regarding how the patient was diagnosed and whether the patient was treated with a pacemaker. After completion of this phase, study investigators will participate in an educational workshop and will be given tools to help them make process improvements within their respective practices. After study investigators implement the tools in Phase II, data from the two phases will be compared to demonstrate the influence of process improvement measures on patient care.

The educational workshop and physician toolkit are the specific interventions being examined in the study. The toolkit will include: diagnostic algorithms, informational videos and resources to educate patients about sinus node dysfunction, available treatment options and information on benefits and risks associated with the various treatments.

“We are committed to improving patient care and providing access to clinically-validated medical solutions in emerging markets,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “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.”

Patient enrollment in Phase I of the IMPROVE Brady study (the control group) will occur for approximately 12 months, or until each region has enrolled 550 patients.  Phase II enrollment will occur for approximately 18 months, or until 1,100 patients per country have been enrolled. The anticipated study duration, from first patient enrollment in Phase I to last patient follow-up in phase II, is 4.5 years for each emerging market participating in the study.

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

Source: Medtronic, Inc.