Cardiac PacingANVITENCT00858559
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
A study testing Implantable cardioverter defibrillator with Home Monitoring function and Standard implantable cardioverter defibrillator in people with Cardiac Pacing and Electric Countershock, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
- What is being tested?
- Implantable cardioverter defibrillator with Home Monitoring function and Standard implantable cardioverter defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for a single-chamber implantable cardioverter-defibrillator (ICD)
Who cannot join
- Contraindication for ICD
- Indication for dual-chamber ICD or cardiac resynchronization therapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Implantable cardioverter defibrillator with Home Monitoring function, Standard implantable cardioverter defibrillator
- Keywords
- Implantable cardioverter defibrillator, Remote monitoring, Follow-up
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable cardioverter defibrillator with Home Monitoring functionDevice
Also called Lumax 500/540 VR-T, CardioMessenger (for Home Monitoring data transmission)
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
Standard implantable cardioverter defibrillatorDevice
Also called Lumax 500/540 VR-T
Implantable cardioverter defibrillators used as standard devices without Home Monitoring
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Home Monitoring Receives: Device: Implantable cardioverter defibrillator with Home Monitoring function |
| 2 | Active comparator | Home Monitoring not used Receives: Device: Standard implantable cardioverter defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant adverse events, especially death, hospitalization, inadequate device therapies
Measured: 27 months
Secondary outcomes (3)
All-cause mortality
Measured: 27 months
Number of device follow-ups
Measured: 27 months
Quality of life
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2011
- Study completionDec 2011
Why it stopped: Stopped due to low enrollment. Patients will be followed up for 3 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Perings, M.D., Principal investigator, Cardiology in Tangram House, Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858559
- Sponsor's protocol ID
- HS047
- Acronym
- ANVITE
- Status last verified
- May 2011
- First submitted
- 9 Mar 2009
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
- ClinicalTrials.gov ID
- NCT00858559
- Acronym / sponsor ID
- ANVITE / HS047
- Keywords
- Implantable cardioverter defibrillator, Remote monitoring, Follow-up
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to low enrollment. Patients will be followed up for 3 months.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Implantable cardioverter defibrillator with Home Monitoring functionHome Monitoring |
| 2 | Active comparator | Device: Standard implantable cardioverter defibrillatorHome Monitoring not used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for a single-chamber implantable cardioverter-defibrillator (ICD)
Key exclusion criteria (2 listed)
- Contraindication for ICD
- Indication for dual-chamber ICD or cardiac resynchronization therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable cardioverter defibrillator with Home Monitoring functionAlso: Lumax 500/540 VR-T, CardioMessenger (for Home Monitoring data transmission)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 | Device | 1 |
| Standard implantable cardioverter defibrillatorAlso: Lumax 500/540 VR-TImplantable cardioverter defibrillators used as standard devices without Home Monitoring | Device | 2 |
Primary outcome
Significant adverse events, especially death, hospitalization, inadequate device therapies
Time frame: 27 months
3 secondary outcomes
All-cause mortality
Time frame: 27 months
Number of device follow-ups
Time frame: 27 months
Quality of life
Time frame: 27 months
Results and safety
The study was stopped early (reason given: Stopped due to low enrollment. Patients will be followed up for 3 months.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Perings, M.D. principal investigator
Cardiology in Tangram House, Düsseldorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable cardioverter defibrillator with Home Monitoring function and Standard implantable cardioverter defibrillator in people with Cardiac Pacing and Electric Countershock, run by Biotronik SE & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped due to low enrollment. Patients will be followed up for 3 months.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant adverse events, especially death, hospitalization, inadequate device therapies (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.