It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D). The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups. All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Quarterly remote follow ups and remote monitoring
Quarterly remote follow ups + additional phone calls and remote monitoring
Quarterly in clinic follow ups and remote monitoring
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, Germany
Asklepios Klinik Bad Oldesloe
Bad Oldesloe, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Evangelisches Krankenhaus Bielefeld gGmbH
Bielefeld, Germany
Evangelisches Krankenhaus Kalk
Cologne, Germany
Universitätsklinikum Essen (AöR)
Essen, Germany
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Asklepios Klinik Barmbek
Hamburg, Germany
Klinikum Ingolstadt GmbH
Ingolstadt, Germany
...and 7 more locations
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
Time frame: 12 months (between 1 and 13 months post implant)
Mortality
Time frame: 12 months (between 1 and 13 months post implant)
Heart failure hospitalizations
Time frame: 12 months (between 1 and 13 months post implant)
Cardiovascular events
Time frame: 12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups
Time frame: 12 months (between 1 and 13 months post implant)
Number of follow ups with relevant findings
Time frame: 12 months (between 1 and 13 months post implant)
Number of delivered / appropriate ICD therapies
Time frame: 12 months (between 1 and 13 months post implant)
Quality of life (MLHFQ)
Time frame: 12 months (between 1 and 13 months post implant)
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