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

Not Applicable

Terminated

• Conditions: Cardiac Pacing; Electric Countershock; Ventricular Tachyarrhythmia
• Interventions: Device: Implantable cardioverter defibrillator with Home Monitoring function; Device: Standard implantable cardioverter defibrillator

• Registration Number: NCT00858559
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Status Verified: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Implantable cardioverter defibrillator with Home Monitoring function	Home Monitoring
2	Standard implantable cardioverter defibrillator	Home Monitoring not used

Primary Outcome Measures

Name	Time	Method
Significant adverse events, especially death, hospitalization, inadequate device therapies	27 months

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	27 months
Number of device follow-ups	27 months
Quality of life	27 months

Trial Locations

Locations (1)

Cardiology in Tangram House; 🇩🇪 Düsseldorf, Germany