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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00858559

Acronym

ANVITE

Enrollment

110

Registered

2009-03-10

Start date

2009-03-31

Completion date

2011-12-31

Last updated

2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia

Keywords

Implantable cardioverter defibrillator, Remote monitoring, Follow-up

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.

Interventions

DEVICEImplantable 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

DEVICEStandard implantable cardioverter defibrillator

Implantable cardioverter defibrillators used as standard devices without Home Monitoring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Significant adverse events, especially death, hospitalization, inadequate device therapies	27 months

Secondary

Measure	Time frame
All-cause mortality	27 months
Number of device follow-ups	27 months
Quality of life	27 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026