Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes desynchronization of the lower chambers of the heart have a higher risk of suffering sudden cardiac death. These patients can be treated with an Implantable Cardiac Defibrillator that terminates dangerously fast heartbeats and in case of asynchronous pumping of the heart can also re-synchronize the lower chambers of the heart (ICD- or CRT-D-system). Patients that moreover suffered from a worsening of their cardiac status (cardiac decompensation) and had to be hospitalized for this reason have a higher risc to have following decompensations. New technology, incorporated into modern Medtronic ICD- and CRT-D-Systems, that measures the amount of water in the lungs is able to warn before such a dangerous worsening occurs. If coupled with modern data transmitting technology (CareLink), automatic information in case of a worsening of the cardiac status can be sent to caregivers, who in turn can react timely in order to prevent a worsening an subsequent hospitalization. The study examines to which extent this new technology prevents potentially adverse cardiac situations and / or hospitalizations and has an influence of the duration of patient´s lives.
The objective of the study is to establish whether the use of event-triggered HF-disease management through Medtronic's OptiVol® fluid status monitoring with an automatically generated wireless CareAlert® notification of the clinician via the Medtronic CareLink® Network can reduce cardiovascular related hospitalizations and the number of deaths in a subject population with HF and ICD / CRT-D treatment as compared to standard clinical assessment. As a measure for the reduction of hospitalizations and deaths the rate of all cause deaths or cardiovascular related hospitalizations will be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,002
Active OptiVol-System with CareAlert via CareLink
Universitätsklinikum des Saarlandes
Homburg-Saar, Saarland, Germany
All-cause of death or unplanned admission to hospital for cardiovascular reason from day of patient informed consent sign off
Time frame: 18 Months
Number of HF-related hospitalization during follow-up, HF-related hospitalization, Sum of follow-up days minus days alive and out of the hospital, All cause mortality, Cardiovascular Mortality,
Time frame: 18 Months
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