Biotronik commences new BIOWOMEN clinical study

Biotronik has commenced a study that aims to evaluate whether women respond better to cardiac resynchronisation therapy (CRT) than men.

The first patient has been enrolled in the BIOWOMEN study, which is the first trial of its size to investigate the topic, thus addressing the urgent medical need for global, gender-specific
clinical trials of heart failure patients.

BIOWOMEN will enroll an even ratio of 247 patients of each sex in 25 centres in nine countries worldwide over the next two years. There will be a one-year follow-up, with results expected in 2018.

The primary endpoint is response to CRT, as measured by left ventricular ejection fraction. Important secondary endpoints are baseline clinical factors, their relation to response and QRS-complex related to CRT response.

Albert Panzeri, vice-president at Biotronik, said: "Through BIOWOMEN we hope to gain insights into the previously unknown question: do women respond better to CRT? If they do, physicians need to know this in order to provide the best care."

The company offers a number of solutions for CRT applications, including its Home Monitoring technology, which makes it easier to track patients' progress in real time.