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

NACompletedINTERVENTIONAL
Enrollment

494

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

December 23, 2021

Study Completion Date

December 23, 2021

Conditions
Heart Failure
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.

Trial Locations (1)

46026

Hospital Clínico Universitario La Fe, Valencia

All Listed Sponsors
lead

Biotronik SE & Co. KG

INDUSTRY

NCT02344420 - Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN | Biotech Hunter | Biotech Hunter