Ventricular ArrythmiasMonitor-ICDNCT00787683
Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
A study testing Home-monitoring provided by LUMAX ICD device and CardioMessenger II in people with Ventricular Arrythmias, run by F. Mueller-Riemenschneider at 13 sites in Germany.
Trial summary
The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Arrythmias
- What is being tested?
- Home-monitoring provided by LUMAX ICD device and CardioMessenger II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 13 sitesGermany
- Study dates
- Oct 2008to Dec 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires
- Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines
Who cannot join
- Age < 18 and > 80 years
- Expected non-compliance
- Known drug or alcohol abuse
- Life expectancy < 1 year
- NYHA classification IV
- Participation in another clinical study
Show all 10Show fewer
- Participation in another telemonitoring concept
- Pregnant or breast-feeding woman
- Uncontrolled hypertension
- No mobile phone use possible in patient residence
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
Hospital Bad Berka
Bad Berka
Cardiological Practice
Bonn, North Rhine-Westphalia, 53127
Hospital Bremerhaven
Bremerhaven, Lower Saxony, 27574
Hospital Coburg
Coburg
University Hospital Göttingen
Göttingen, 37099
Asklepios Hospital Barmbeck in Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 22291
MH-Hannover
Hanover, Lower Saxony, 30625
Heart Centre Bodensee Konstanz
Konstanz
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
University Hospital Münster
Münster
St. Vincenz Hospital Paderborn
Paderborn, North Rhine-Westphalia, 33098
Academic Teaching Hospital Villingen of the University of Freiburg
Villingen-Schwenningen
About this study
Official title: Home-Monitoring in ICD Patients
The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.
Read the detailed description
Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer.
The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.
- Conditions
- Ventricular Arrythmias
- Being tested
- Home-monitoring provided by LUMAX ICD device and CardioMessenger II
- Keywords
- Patients with ventricular arrhythmias and the prevention of sudden cardiac death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-monitoring provided by LUMAX ICD device and CardioMessenger IIDevice
Also called Home-monitoring, Remote-monitoring, Tele-monitoring, ICD
All study participants receive an ICD of the Biotronik lumax family. Only participants of the intervention group receive the CardioMessengerII to allow for transmission of regular home monitoring messages. All study participants will be followed for 12 to 24 months (depending on the time of recruitment). The intervention and comparison to be investigated is home-monitoring vs. no home-monitoring. The intervention involves a combination of in-clinic consultations and regular use of home-monitoring services. As part of the modified follow-up schedule of intervention patients compared to standard care, follow-up in-clinic consultations 3, 6, and 18 months after ICD implantation will be replaced by home-monitoring follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Home-monitoring | Experimental | Patients receive an additional home-monitoring (remote-monitoring) device (CardioMessengerII) following Biotronik Lumax ICD implantation. The device enables regular transmission and examination of ICD information via home-monitoring. Follow-up appointments in outpatient clinic are changed compared to standard care. While follow-up 1, 12, and 24 months after ICD implantation consist of outpatient clinic appointments, follow-up 3, 6, and 18 months after ICD implantation are conducted remotely. Receives: Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II |
| Standard care | No intervention | Patients randomised to the standard care group receive no home-monitoring device (CardioMessengerII) following Lumax ICD implantation. Patients have scheduled follow-up appointments at the ICD outpatient clinics at 1, 3, 6, 12, 18, and 24 months after ICD implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of disease specific costs from a societal perspective.
Measured: up to 24 months
Secondary outcomes (6)
Number of shocks
Measured: up to 24 months
Hospital admissions
Measured: up to 24 months
Cardiac events
Measured: up to 24 months
Quality of life
Measured: up to 24 months
Disease specific Costs from third party payers perspective
Measured: up 24 months
Overall costs from societal and third party payers perspective
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrythmiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F. Mueller-Riemenschneider
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor-investigator, F. Mueller-Riemenschneider, Charite University, Berlin, Germany
- Investigators
- Markus Zabel, Prof., MD, Principal investigator, Medical Faculty, University of Göttingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787683
- Sponsor's protocol ID
- V7.0
- Acronym
- Monitor-ICD
- Status last verified
- Jun 2012
- First submitted
- 6 Nov 2008
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zabel M, Muller-Riemenschneider F, Geller JC, Brachmann J, Kuhlkamp V, Dissmann R, Reinhold T, Roll S, Luthje L, Bode F, Eckardt L, Willich SN; MONITOR-ICD investigators. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators. Am Heart J. 2014 Oct;168(4):430-7. doi: 10.1016/j.ahj.2014.04.021. Epub 2014 Jun 13.
PubMed 25262251
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Monitoring in ICD Patients
- ClinicalTrials.gov ID
- NCT00787683
- Acronym / sponsor ID
- Monitor-ICD / V7.0
- Conditions
- Ventricular Arrythmias
- Keywords
- Patients with ventricular arrhythmias and the prevention of sudden cardiac death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- F. Mueller-RiemenschneiderUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- Oct 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Nov 2008 (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.
The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.
Detailed description
Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer.
The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-monitoring | Experimental | Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger IIPatients receive an additional home-monitoring (remote-monitoring) device (CardioMessengerII) following Biotronik Lumax ICD implantation. The device enables regular transmission and examination of ICD information via home-monitoring. Follow-up appointments in outpatient clinic are changed compared to standard care. While follow-up 1, 12, and 24 months after ICD implantation consist of outpatient clinic appointments, follow-up 3, 6, and 18 months after ICD implantation are conducted remotely. |
| Standard care | No intervention | –Patients randomised to the standard care group receive no home-monitoring device (CardioMessengerII) following Lumax ICD implantation. Patients have scheduled follow-up appointments at the ICD outpatient clinics at 1, 3, 6, 12, 18, and 24 months after ICD implantation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires
- Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines
Key exclusion criteria (10 listed)
- Age < 18 and > 80 years
- Expected non-compliance
- Known drug or alcohol abuse
- Life expectancy < 1 year
- NYHA classification IV
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 |
|---|---|---|
| Home-monitoring provided by LUMAX ICD device and CardioMessenger IIAlso: Home-monitoring, Remote-monitoring, Tele-monitoring, ICDAll study participants receive an ICD of the Biotronik lumax family. Only participants of the intervention group receive the CardioMessengerII to allow for transmission of regular home monitoring messages. All study participants will be followed for 12 to 24 months (depending on the time of recruitment). The intervention and comparison to be investigated is home-monitoring vs. no home-monitoring. The intervention involves a combination of in-clinic consultations and regular use of home-monitoring services. As part of the modified follow-up schedule of intervention patients compared to standard care, follow-up in-clinic consultations 3, 6, and 18 months after ICD implantation will be replaced by home-monitoring follow-up. | Device | Home-monitoring |
Primary outcome
Comparison of disease specific costs from a societal perspective.
Time frame: up to 24 months
6 secondary outcomes
Number of shocks
Time frame: up to 24 months
Hospital admissions
Time frame: up to 24 months
Cardiac events
Time frame: up to 24 months
Quality of life
Time frame: up to 24 months
Disease specific Costs from third party payers perspective
Time frame: up 24 months
Overall costs from societal and third party payers perspective
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Derived from this study: PubMed 25262251Zabel M, Muller-Riemenschneider F, Geller JC, Brachmann J, Kuhlkamp V, Dissmann R, Reinhold T, Roll S, Luthje L, Bode F, Eckardt L, Willich SN; MONITOR-ICD investigators. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators. Am Heart J. 2014 Oct;168(4):430-7. doi: 10.1016/j.ahj.2014.04.021. Epub 2014 Jun 13.
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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.
Markus Zabel, Prof., MD principal investigator
Medical Faculty, University of Göttingen, Germany
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-monitoring provided by LUMAX ICD device and CardioMessenger II in people with Ventricular Arrythmias, run by F. Mueller-Riemenschneider at 13 sites 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
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?
Comparison of disease specific costs from a societal perspective. (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00787683, which also lists 1 linked publication.
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 26 Jun 2012.