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

This study has been terminated.
(Stopped due to low enrollment. Patients will be followed up for 3 months.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00858559
First Posted: March 10, 2009
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 27 months ]
  • Number of device follow-ups [ Time Frame: 27 months ]
  • Quality of life [ Time Frame: 27 months ]

Enrollment: 110
Study Start Date: March 2009
Study Completion Date: December 2011
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00858559     History of Changes
Other Study ID Numbers: HS047
First Submitted: March 9, 2009
First Posted: March 10, 2009
Last Update Posted: August 4, 2017
Last Verified: May 2011

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

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