BIO|WOMEN Clinical Trial

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