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

NCT02344420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2022-01-20

No results posted yet for this study

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

Interventions

PROCEDURE

Echocardiography

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.

BEHAVIORAL

Minnesota Living Heart Failure Questionnaire (MLHF)

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.

PROCEDURE

Six minute walk test

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.

BEHAVIORAL

Self assessment score

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

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344420 on ClinicalTrials.gov