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

NCT02344420 | Completed DMC

• 1 other identifier: BIOTRONIK-CR017
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response rate in a Heart Failure (HF) population with an equal distribution of men and women. Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF etiology…) and compared in order to demonstrate that women may respond even better than men.

Conditions

Heart Failure

Keywords

Heart Failure; CRT

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction (LVEF) changes at 12 month Follow Up (FU)

  To study the magnitude of Cardiac Resynchronization Therapy (CRT) response in women measured as a function of improvement in LVEF at 12moth FU in order to demonstrate that CRT response in women is better than men.

  Baseline, 6 and 12 month

Secondary Outcomes (7)

• Left Ventricular End Diastolic Volume (LVEDV)

  Baseline, 6 and 12 month

• Left Ventricular End Systolic Volume (LVESV)

  Baseline, 6 and 12 month

• NYHA class

  Baseline, 6 and 12 month Follow Up

• Quality Of Life test (QOL score)

  Baseline, 6 and 12 month Follow Up

• Patient's global self-assessment score

  2, 6 and 12 month Follow Up

Study Arms (1)

Single Arm

OTHER

As it is not a randomize trial there is only one study arm. Described interventions as echocariography, six minute walk test, Quality of Life test or self assessment score should be done in all patients.

Procedure: Echocardiography; Behavioral: Minnesota Living Heart Failure Questionnaire (MLHF); Procedure: Six minute walk test; Behavioral: Self assessment score

Interventions

Echocardiography PROCEDURE

The devices used within the study are the legally marked CRT devices from BIOTRONIK. CRT-P and CRT-D. As this is a post market study, all devices have a CE label and are used within their intended use. There are no study specific limitations nor mandatory device settings for the study. Subjects will undergo a standard echo assessment at baseline, 6 and 12 month follow up visit in order to assess the baseline characteristics and the changes as response to resynchronization.

Single Arm

Minnesota Living Heart Failure Questionnaire (MLHF) BEHAVIORAL

MLHF will be obtained at baseline, 6 and 12 month FU. The goal of this questionnaire is to measure the subjects perception of how their heart failure and treatment affect their life. Questions are focused on physical, socio-economic, and psychological impairments that persons with congestive heart failure frequently attribute to their condition.

Single Arm

Six minute walk test PROCEDURE

The test will be performed at baseline, 6 and 12 month FU. The purpose of the test is to determine how far a patient can walk in six minute and relate it with the heart failure.

Single Arm

Self assessment score BEHAVIORAL

patient will complete a self assessment questionnaire at 2, 6 and 12 month FU for the calculation of the Packer Score at 12 month.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for a "De Novo" implantation of a CRT device according to ESC Guidelines
• Understand the nature of the procedure
• Give written informed consent

You may not qualify if:

• CRT Device replacements
• CRT upgrades
• Permanent / Persistent Atrial Fibrillation
• Age\< 18 years
• Pregnant and breastfeeding women
• Subjects with irreversible brain damage from pre existing cerebral disease
• Subjects with acutely de compensated heart failure
• NYHA Class IV Heart Failure
• Heart transplantation six months prior to the enrolment or expected within next 3 months.
• Cardiac surgery 3 months prior to the enrolment or planned within next 3 months.
• Have a life expectancy of less than 12 months

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (1)

Hospital Clínico Universitario La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Maria Jose MS Sancho-Tello, Physician

  Hospital Universitario La Fe de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: January 26, 2015
• Study Start: August 1, 2015
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: January 20, 2022

Record last verified: 2021-10

Locations

ES (1)