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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Quarterly remote follow ups and remote monitoring; Other: Quarterly remote follow ups + additional phone calls and remote monitoring; Other: Quarterly in clinic follow ups and remote monitoring

• 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

Arm && Interventions

Group	Intervention	Description
Group A	Quarterly remote follow ups and remote monitoring	Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)
Group B1	Quarterly remote follow ups + additional phone calls and remote monitoring	Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)
Group B2	Quarterly in clinic follow ups and remote monitoring	Personal ICD/CRTD follow up (Quarterly visits)

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 delivered / appropriate ICD therapies	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)
Quality of life (MLHFQ)	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)
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)

Trial Locations

Locations (17)

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald; 🇩🇪 Bad Friedrichshall, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Asklepios Klinik Bad Oldesloe; 🇩🇪 Bad Oldesloe, Germany

Evangelisches Krankenhaus Bielefeld gGmbH; 🇩🇪 Bielefeld, Germany

Universitätsklinikum Essen (AöR); 🇩🇪 Essen, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH; 🇩🇪 Göttingen, Germany

Asklepios Klinik Barmbek; 🇩🇪 Hamburg, Germany

Kardiologische Praxis - Partnergesellschaft; 🇩🇪 Ludwigsburg, Germany

Evangelisches Krankenhaus Kalk; 🇩🇪 Köln, Germany

Klinikum Ingolstadt GmbH; 🇩🇪 Ingolstadt, Germany

Städtisches Klinikum Lüneburg gGmbH; 🇩🇪 Lüneburg, Germany

Marienhaus Klinikum St. Elisabeth-Krankenhaus; 🇩🇪 Neuwied, Germany

Praxis Dr. med. Balbach / Ruppert; 🇩🇪 Nürtingen, Germany

Kardiologische Gemeinschaftspraxis am Park Sanssouci; 🇩🇪 Potsdam, Germany

Klinikum Sindelfingen-Böblingen gGmbH; 🇩🇪 Sindelfingen, Germany

Marienhospital Stuttgart; 🇩🇪 Stuttgart, Germany