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| Sponsored by: |
Biotronik GmbH & Co. KG |
|---|---|
| Information provided by: | Biotronik GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00858559 |
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: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE) |
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Active Comparator
Home Monitoring not used
|
Device: Standard implantable cardioverter defibrillator
Implantable cardioverter defibrillators used as standard devices without Home Monitoring
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Frank Miermeister, Ph.D. | +49913189247870 | frank.miermeister@biotronik.com |
| Germany | |
| Cardiology in Tangram House | |
| Düsseldorf, Germany, 40237 | |
| Principal Investigator: | Stefan Perings, M.D. | Cardiology in Tangram House, Düsseldorf, Germany |
More Information
| Responsible Party: | Biotronik GmbH & Co. KG ( Frank Miermeister ) |
| Study ID Numbers: | HS047 |
| Study First Received: | March 9, 2009 |
| Last Updated: | March 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00858559 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Implantable cardioverter defibrillator Remote monitoring Follow-up |
|
Heart Diseases Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac |
|
Pathologic Processes Heart Diseases Tachycardia |
Cardiovascular Diseases Tachycardia, Ventricular Arrhythmias, Cardiac |
