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

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT01200381
• Lead Sponsor: Abbott Medical Devices

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of follow ups with relevant findings	12 months (between 1 and 13 months post implant)
Heart failure hospitalizations	12 months (between 1 and 13 months post implant)
Cardiovascular events	12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups	12 months (between 1 and 13 months post implant)
Quality of life (MLHFQ)	12 months (between 1 and 13 months post implant)
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)

Trial Locations

Locations (17)

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

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

Evangelisches Krankenhaus Kalk; 🇩🇪 Köln, Germany

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