INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01200381

Acronym

InContact

Enrollment

210

Registered

2010-09-13

Start date

2010-02-28

Completion date

2014-07-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

ICD, CRTD, Remote care, Remote monitoring, Heart failure

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

Interventions

OTHERQuarterly remote follow ups and remote monitoring

Quarterly remote follow ups and remote monitoring

OTHERQuarterly remote follow ups + additional phone calls and remote monitoring

Quarterly remote follow ups + additional phone calls and remote monitoring

OTHERQuarterly in clinic follow ups and remote monitoring

Quarterly in clinic follow ups and remote monitoring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Amount of patients with worsened outcome in reference to Packer's Heart Failure Clinical Composite Response	12 months (between 1 and 13 months post implant)

Secondary

Measure	Time frame
Number of delivered / appropriate ICD therapies	12 months (between 1 and 13 months post implant)
Mortality	12 months (between 1 and 13 months post implant)
Heart failure hospitalizations	12 months (between 1 and 13 months post implant)
Quality of life (MLHFQ)	12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups	12 months (between 1 and 13 months post implant)
Number of follow ups with relevant findings	12 months (between 1 and 13 months post implant)
Cardiovascular events	12 months (between 1 and 13 months post implant)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026