Clinical trial NCT01200381: INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
Official title: INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: ICD
CRTD
Remote care
Remote monitoring
Heart failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
* Written informed consent
* Ejection Fraction \<= 35%
* New York Heart Association (NYHA) Class I-III
* Age \>=18 and \<=80 years
* In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available

Exclusion Criteria:

* Arterio ventricular (AV) Block III / AV Block II Type Mobitz
* Severe renal insufficiency
* Coronary angiology intervention within previous 3 months
* Myocardial infarction within previous month
* Life expectancy \< 1 year
* Expected poor data quality / compliance
* Pregnancy
* Patient is already participating to another study with active therapy arm

Primary outcomes:
measure: Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
timeFrame: 12 months (between 1 and 13 months post implant)
Secondary outcomes:
measure: Mortality
timeFrame: 12 months (between 1 and 13 months post implant)
measure: Heart failure hospitalizations
timeFrame: 12 months (between 1 and 13 months post implant)
measure: Cardiovascular events
timeFrame: 12 months (between 1 and 13 months post implant)
measure: Number of additional, unscheduled follow ups
timeFrame: 12 months (between 1 and 13 months post implant)
measure: Number of follow ups with relevant findings
timeFrame: 12 months (between 1 and 13 months post implant)
measure: Number of delivered / appropriate ICD therapies
timeFrame: 12 months (between 1 and 13 months post implant)
measure: Quality of life (MLHFQ)
timeFrame: 12 months (between 1 and 13 months post implant)
Other outcomes:
Locations:
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
city: Bad Oldesloe
country: Germany
facility: Asklepios Klinik Bad Oldesloe
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld gGmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR)
city: Göttingen
country: Germany
facility: Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt GmbH
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk
city: Ludwigsburg
country: Germany
facility: Kardiologische Praxis - Partnergesellschaft
city: Lüneburg
country: Germany
facility: Städtisches Klinikum Lüneburg gGmbH
city: Neuwied
country: Germany
facility: Marienhaus Klinikum St. Elisabeth-Krankenhaus
city: Nürtingen
country: Germany
facility: Praxis Dr. med. Balbach / Ruppert
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
city: Sindelfingen
country: Germany
facility: Klinikum Sindelfingen-Böblingen gGmbH
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart
Study officials:
affiliation: Städtisches Klinikum Lüneburg gGmbH
name: Christian Weiss, Prof. Dr. med.
role: STUDY_CHAIR
References:
citation: Hansen C, Loges C, Seidl K, Eberhardt F, Troster H, Petrov K, Gronefeld G, Bramlage P, Birkenhauer F, Weiss C. INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact). BMC Cardiovasc Disord. 2018 Jun 28;18(1):131. doi: 10.1186/s12872-018-0864-7.