Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE) (ANVITE)

August 3, 2017 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40237
        • Cardiology in Tangram House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Home Monitoring
Device: Implantable cardioverter defibrillator with Home Monitoring function
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
Other Names:
  • Lumax 500/540 VR-T
  • CardioMessenger (for Home Monitoring data transmission)
Active Comparator: 2
Home Monitoring not used
Device: Standard implantable cardioverter defibrillator
Implantable cardioverter defibrillators used as standard devices without Home Monitoring
Other Names:
  • Lumax 500/540 VR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant adverse events, especially death, hospitalization, inadequate device therapies
Time Frame: 27 months
27 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 27 months
27 months
Number of device follow-ups
Time Frame: 27 months
27 months
Quality of life
Time Frame: 27 months
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Stefan Perings, M.D., Cardiology in Tangram House, Düsseldorf, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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