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

Biotronik

Status: Terminated

Conditions: Cardiac Pacing; Electric Countershock; Ventricular Tachyarrhythmia

Treatments: Device: Standard implantable cardioverter defibrillator; Device: Implantable cardioverter defibrillator with Home Monitoring function

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858559

HS047

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

1

Experimental group

Description:

Home Monitoring

Treatment:

Device: Implantable cardioverter defibrillator with Home Monitoring function

2

Active Comparator group

Description:

Home Monitoring not used

Treatment:

Device: Standard implantable cardioverter defibrillator