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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
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Pacing
Electric Countershock
Ventricular Tachyarrhythmia
 Device: Implantable cardioverter defibrillator with Home Monitoring function
Device: Standard implantable cardioverter defibrillator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Significant adverse events, especially death, hospitalization, inadequate device therapies [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Home Monitoring
 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)
Active Comparator: 2
Home Monitoring not used
 Device: Standard implantable cardioverter defibrillator
Implantable cardioverter defibrillators used as standard devices without Home Monitoring
Other Name: Lumax 500/540 VR-T

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858559

Locations
Germany
Cardiology in Tangram House
Düsseldorf, Germany, 40237
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Stefan Perings, M.D. Cardiology in Tangram House, Düsseldorf, Germany
  More Information

No publications provided

Responsible Party: Dr. Frank Miermeister, Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00858559     History of Changes
Other Study ID Numbers: HS047
Study First Received: March 9, 2009
Last Updated: May 19, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Implantable cardioverter defibrillator
Remote monitoring
Follow-up

Additional relevant MeSH terms:
Tachycardia, Ventricular
Tachycardia
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013