Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-07-31

Brief Summary

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The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause. The probability of the first therapy due to ventricular tachyarrhythmia was about 34% within 3 years. With a 3-month ICD-follow-up scheme, as it is in the standard ICD therapy, the majority of patients is followed more closely than necessary with respect to anti-tachyarrhythmia ICD therapy.

A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik (Berlin , Germany), for close remote monitoring of ICD patients. The HM function may substitute in-clinic follow-up controls.

The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month follow-up scheme using HM in ICD recipients with the "MADIT II indications". The comparison should be made with respect to the difference in follow-up burden and the associated costs, and regarding possible impact of the remote follow-up via HM on all cause mortality, hospitalization, and patients' quality of life.

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Detailed Description

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The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause. The probability of the 1st therapy due to ventricular tachyarrhythmia was about 34% within 3 years, with an increasing incidence from year 1 to 3. With a 3-month ICD-follow-up scheme, as it is in the standard ICD therapy, the majority of patients is followed more closely than necessary with respect to anti-tachyarrhythmia ICD therapy.

A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik (Berlin , Germany), for close remote monitoring of ICD patients. The HM function automatically transmits predefined parameters on a daily basis from the implanted devices to a web-based platform accessible only by registered patients' physicians. These data may substitute in-clinical follow-up controls.

The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month follow-up scheme using HM in ICD recipients with the "MADIT II indications". The comparison should be made with respect to the difference in follow-up burden and the associated costs, and regarding possible impact of the remote follow-up via HM on all cause mortality, hospitalization, and patients' quality of life.

The patients should receive single- or dual-chamber ICD models with the HM function.

The pre-hospital-discharge protocol comprises standard ICD follow-up + specific ICD programming, and activation of the HM function. The 1st standard follow-up visit is performed 3 months after the pre-discharge control. At this visit the patients are randomized to 3- vs. 12-month follow-up scheme. For the 3-month follow-up group, routine visits are scheduled at 6, 9, 12, 15, 18, 21, 24, and 27 months after patient discharge. For the 12-month (remote) follow-up group, routine visits are scheduled at 15 and 27 months after discharge. In either group, additional visits are scheduled on patient demand, due to device or lead problems, or due to the following Cardio Report (Home Monitoring) findings: Elective ICD replacement point, the 1st shock after discharge, an ineffective shock, ineffective anti-tachycardia pacing, ventricular pacing impedance outside the pre-defined range, shock impedance lower than 25 Ohm or greater than 110 Ohm, frequent arrhythmia episodes (according to pre-specified criteria).

Conditions

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Ventricular Fibrillation Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Prolonged follow-up intervals every 12 months

Group Type EXPERIMENTAL

Implantable Cardioverter Defibrillator

Intervention Type DEVICE

ICD with Biotronik Home Monitoring capability

2

Standard follow-up intervals of 3 months

Group Type ACTIVE_COMPARATOR

Implantable Cardioverter Defibrillator

Intervention Type DEVICE

ICD with Biotronik Home Monitoring capability

Interventions

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Implantable Cardioverter Defibrillator

ICD with Biotronik Home Monitoring capability

Intervention Type DEVICE

Other Intervention Names

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Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T

Eligibility Criteria

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Inclusion Criteria

Indication for implantation of an implantable cardioverter-defibrillator (ICD) according to the patient selection criteria used in the MADIT-II trial:

* Myocardial infarction 1 month or more prior to entry
* Ejection fraction of 30% or less within 3 months before entry

Exclusion Criteria

* NYHA functional class IV
* Coronary revascularization later than 5 days after ICD implantation
* First myocardial infarction within the past month
* Advanced cerebrovascular disease
* Any condition with a likelihood of death within the next 12 months
* Pacing indication
* Conventional ICD indication (i.e., criteria other than MADIT II)
* Living in an area with insufficient GSM coverage

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No