NCT00858559

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2009-03-10
• Last updated: 2017-08-04

Locations

1 site across 1 country: Germany