BIO Women

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