Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE) (ANVITE)
Primary Purpose
Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implantable cardioverter defibrillator with Home Monitoring function
Standard implantable cardioverter defibrillator
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiac Pacing focused on measuring Implantable cardioverter defibrillator, Remote monitoring, Follow-up
Eligibility 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
Sites / Locations
- Cardiology in Tangram House
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Home Monitoring
Home Monitoring not used
Outcomes
Primary Outcome Measures
Significant adverse events, especially death, hospitalization, inadequate device therapies
Secondary Outcome Measures
All-cause mortality
Number of device follow-ups
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00858559
Brief Title
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Acronym
ANVITE
Official Title
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to low enrollment. Patients will be followed up for 3 months.
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
Keywords
Implantable cardioverter defibrillator, Remote monitoring, Follow-up
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Home Monitoring
Arm Title
2
Arm Type
Active Comparator
Arm Description
Home Monitoring not used
Intervention Type
Device
Intervention Name(s)
Implantable cardioverter defibrillator with Home Monitoring function
Other Intervention Name(s)
Lumax 500/540 VR-T, CardioMessenger (for Home Monitoring data transmission)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard implantable cardioverter defibrillator
Other Intervention Name(s)
Lumax 500/540 VR-T
Intervention Description
Implantable cardioverter defibrillators used as standard devices without Home Monitoring
Primary Outcome Measure Information:
Title
Significant adverse events, especially death, hospitalization, inadequate device therapies
Time Frame
27 months
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
27 months
Title
Number of device follow-ups
Time Frame
27 months
Title
Quality of life
Time Frame
27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Perings, M.D.
Organizational Affiliation
Cardiology in Tangram House, Düsseldorf, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology in Tangram House
City
Düsseldorf
ZIP/Postal Code
40237
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
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