BIO|WOMEN

Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN

Study Design

Prospective, multicenter, international study
Evaluates gender differences in the magnitude of CRT response in a heart failure population
494 patients planned – ongoing study

Study Objectives	BIO\|WOMEN is a study designed to compare the CRT response rate in a heart failure population with an equal distribution of men and women
1° Endpoints	Magnitude of CRT response measured as a function of increase in left ventricular ejection fraction (LVEF) at 12 month follow up (FU)
2° Endpoints	LVEDV and LVESV changes in both populations with CRT response LVEDV and LVESV changes in both populations with CRT response Relationship between QRS duration (amount of asynchrony) and CRT response in both populations
Clinical Sites	27 sites in 8 countries (Austria, Belgium, Germany, Israel, Italy, Netherlands, Spain, UK)
Sample Size	494 patients planned – ongoing study
Inclusion Criteria	Indication for a de novo implantation of a CRT device
Main Exclusion Criteria	CRT device replacements or upgrades Permanent/persistent atrial fibrillation Cardiac surgery 3 months prior to the enrolment or planned within next 3 months Heart transplantation 6 months prior to the enrolment or expected within next 3 months Have a life expectancy of less than 12 months Subjects with irreversible brain damage from pre existing cerebral disease Subjects with acutely decompensated heart failure NYHA class IV heart failure
Devices	BIOTRONIK CRT-Ds
Follow-Up	Follow-up period 12 month
Study Duration	June 2015 - ongoing
Reference No.	NCT02344420
Principal Investigator	Maria Jose Sancho-Tello, Hospital Universitario La Fe de Valencia