Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

Not Applicable

• Conditions: Ventricular Arrythmias

• Registration Number: NCT00787683
• Lead Sponsor: F. Mueller-Riemenschneider

Brief Summary

The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.

Detailed Description

Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer.

The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-26
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires
• Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines

Exclusion Criteria

• Age < 18 and > 80 years
• Expected non-compliance
• Known drug or alcohol abuse
• Life expectancy < 1 year
• NYHA classification IV
• Participation in another clinical study
• Participation in another telemonitoring concept
• Pregnant or breast-feeding woman
• Uncontrolled hypertension
• No mobile phone use possible in patient residence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of disease specific costs from a societal perspective.	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Number of shocks	up to 24 months
Hospital admissions	up to 24 months
Cardiac events	up to 24 months
Quality of life	up to 24 months
Disease specific Costs from third party payers perspective	up 24 months
Overall costs from societal and third party payers perspective	up to 24 months

Trial Locations

Locations (13)

Hospital Bremerhaven; 🇩🇪 Bremerhaven, Niedersachsen, Germany

MH-Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

University Hospital Aachen; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany

Cardiological Practice; 🇩🇪 Bonn, Nordrhein-Westfalen, Germany

St. Vincenz Hospital Paderborn; 🇩🇪 Paderborn, Nordrhein-Westfalen, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Hospital Bad Berka; 🇩🇪 Bad Berka, Germany

Hospital Coburg; 🇩🇪 Coburg, Germany

University Hospital Göttingen; 🇩🇪 Göttingen, Germany

Asklepios Hospital Barmbeck in Hamburg; 🇩🇪 Hamburg, Germany

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