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

Cardiac Pacing Clinical Trial

— ANVITE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00858559
• Other study ID #: HS047
• Status: Terminated
• Phase: N/A
• First received: March 9, 2009
• Last updated: August 3, 2017
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Pacing
• Electric Countershock
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachyarrhythmia

Intervention

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
• Standard implantable cardioverter defibrillator
Implantable cardioverter defibrillators used as standard devices without Home Monitoring

Locations

Country	Name	City	State
Germany	Cardiology in Tangram House	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant adverse events, especially death, hospitalization, inadequate device therapies		27 months
Secondary	All-cause mortality		27 months
Secondary	Number of device follow-ups		27 months
Secondary	Quality of life		27 months