Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

F. Mueller-Riemenschneider416 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

416

Conditions

Ventricular Arrythmias

Interventions

Home-monitoring provided by LUMAX ICD device and CardioMessenger IIDEVICE

All study participants receive an ICD of the Biotronik lumax family. Only participants of the intervention group receive the CardioMessengerII to allow for transmission of regular home monitoring messages. All study participants will be followed for 12 to 24 months (depending on the time of recruitment). The intervention and comparison to be investigated is home-monitoring vs. no home-monitoring. The intervention involves a combination of in-clinic consultations and regular use of home-monitoring services. As part of the modified follow-up schedule of intervention patients compared to standard care, follow-up in-clinic consultations 3, 6, and 18 months after ICD implantation will be replaced by home-monitoring follow-up.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (13)

Asklepios Hospital Barmbeck in Hamburg

Hamburg, Hamburg, Germany

Hospital Bremerhaven

Bremerhaven, Lower Saxony, Germany

MH-Hannover

Hanover, Lower Saxony, Germany

Outcomes

Primary Outcomes

Comparison of disease specific costs from a societal perspective.

Time frame: up to 24 months

Secondary Outcomes

Number of shocks

Time frame: up to 24 months

Hospital admissions

Time frame: up to 24 months

Cardiac events

Time frame: up to 24 months

Quality of life

Time frame: up to 24 months

Disease specific Costs from third party payers perspective

Time frame: up 24 months

Overall costs from societal and third party payers perspective

Time frame: up to 24 months

Data from ClinicalTrials.gov

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