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

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Other: Quarterly remote follow ups and remote monitoring; Other: Quarterly in clinic follow ups and remote monitoring; Other: Quarterly remote follow ups + additional phone calls and remote monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT01200381

T94

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Group A

Active Comparator group

Description:

Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)

Treatment:

Other: Quarterly remote follow ups and remote monitoring

Group B1

Active Comparator group

Description:

Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)

Treatment:

Other: Quarterly remote follow ups + additional phone calls and remote monitoring

Group B2

Active Comparator group

Description:

Personal ICD/CRTD follow up (Quarterly visits)

Treatment:

Other: Quarterly in clinic follow ups and remote monitoring