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BIO|WOMEN Clinical Trial

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

Study Details

Study Objective

  • 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

Primary Endpoint

  • Magnitude of CRT response measured as a function of increase in left ventricular ejection fraction (LVEF) at 12 month follow up (FU)

Secondary Endpoints

  • 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

Main 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 months

Study Duration

  • June 2015 - December 2021

Reference no.

  • NCT02344420

Principal Investigators

  • Maria Jose Sancho-Tello, Hospital Universitario La Fe de Valencia

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