NCT00858559

Brief Summary

Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician. In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 4, 2017

Status Verified

May 1, 2011

Enrollment Period

2.5 years

First QC Date

March 9, 2009

Last Update Submit

August 3, 2017

Conditions

Cardiac PacingElectric CountershockVentricular Tachyarrhythmia

Keywords

Implantable cardioverter defibrillatorRemote monitoringFollow-up

Outcome Measures

Primary Outcomes (1)

  • Significant adverse events, especially death, hospitalization, inadequate device therapies

    27 months

Secondary Outcomes (3)

  • All-cause mortality

    27 months

  • Number of device follow-ups

    27 months

  • Quality of life

    27 months

Study Arms (2)

1

EXPERIMENTAL

Home Monitoring

Device: Implantable cardioverter defibrillator with Home Monitoring function

2

ACTIVE COMPARATOR

Home Monitoring not used

Device: Standard implantable cardioverter defibrillator

Interventions

Implantable cardioverter defibrillator with Home Monitoring functionDEVICE

Implantable cardioverter defibrillators can send data from its diagnostic and therapy memory via wireless Home Monitoring on a daily basis to an internet based platform, securely accessed by the attending physician

Also known as: Lumax 500/540 VR-T, CardioMessenger (for Home Monitoring data transmission)
1
Standard implantable cardioverter defibrillatorDEVICE

Implantable cardioverter defibrillators used as standard devices without Home Monitoring

Also known as: Lumax 500/540 VR-T
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for a single-chamber implantable cardioverter-defibrillator (ICD)

You may not qualify if:

  • Contraindication for ICD
  • Indication for dual-chamber ICD or cardiac resynchronization therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology in Tangram House

Düsseldorf, 40237, Germany

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Stefan Perings, M.D.

    Cardiology in Tangram House, Düsseldorf, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

August 4, 2017

Record last verified: 2011-05

Locations

DE(1)