MedTrace Logo

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

NCT00858559 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-08-04

No results posted yet for this study

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.

Conditions

  • Cardiac Pacing
  • Electric Countershock
  • Ventricular Tachyarrhythmia

Interventions

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

DEVICE

Standard implantable cardioverter defibrillator

Implantable cardioverter defibrillators used as standard devices without Home Monitoring

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Stefan Perings, M.D. · Cardiology in Tangram House, Düsseldorf, Germany

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858559 on ClinicalTrials.gov