494
Participants
Start Date
August 31, 2015
Primary Completion Date
December 23, 2021
Study Completion Date
December 23, 2021
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."
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.
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.
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.
Hospital Clínico Universitario La Fe, Valencia
Biotronik SE & Co. KG
INDUSTRY