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

This study has been terminated.
(Stopped due to low enrollment. Patients will be followed up for 3 months.)
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00858559
First received: March 9, 2009
Last updated: May 19, 2011
Last verified: May 2011

March 9, 2009
May 19, 2011
March 2009
September 2011   (final data collection date for primary outcome measure)
Significant adverse events, especially death, hospitalization, inadequate device therapies [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00858559 on ClinicalTrials.gov Archive Site
  • All-cause mortality [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
  • Number of device follow-ups [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 27 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cardiac Pacing
  • Electric Countershock
  • Ventricular Tachyarrhythmia
  • 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
    Other Names:
    • Lumax 500/540 VR-T
    • CardioMessenger (for Home Monitoring data transmission)
  • Device: Standard implantable cardioverter defibrillator
    Implantable cardioverter defibrillators used as standard devices without Home Monitoring
    Other Name: Lumax 500/540 VR-T
  • Experimental: 1
    Home Monitoring
    Intervention: Device: Implantable cardioverter defibrillator with Home Monitoring function
  • Active Comparator: 2
    Home Monitoring not used
    Intervention: Device: Standard implantable cardioverter defibrillator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
110
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00858559
HS047
No
Dr. Frank Miermeister, Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
Principal Investigator: Stefan Perings, M.D. Cardiology in Tangram House, Düsseldorf, Germany
Biotronik SE & Co. KG
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP