Pacemaker, ArtificialCOMPASNCT00989326
Evaluate the Benefits of Pacemaker Follow-Up With Home-Monitoring
A study testing Home Monitoring in people with Pacemaker, Artificial and Bradycardia, run by Biotronik France at 1 site in France.
Trial summary
The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pacemaker, Artificial, Bradycardia
- What is being tested?
- Home Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2005to Oct 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is willing and able to comply with the protocol
- The patient has provided written informed consent
- Patient whose medical situation is stable
- Patient with PHILOS II DR-T Pacemaker >= one month with A/V bipolar lead
- No change of residence expected during study
Who cannot join
- Spontaneous Ventricular Rhythm < 30 ppm
- Heart failure no controlled by medical treatment
- Post cardiac surgery (< 1 month)
- Post myocardial infarction (< 1 month)
- More than two cardioversion shocks for last 6 month
- A/V Lead dislodgement, or/and impedance, threshold, or sensing failure
Show all 13Show fewer
- Pocket hematoma with needed intervention
- Pneumothorax / Hemothorax
- Infection
- Automatic Ventricular Threshold Test cannot be realised
- Patient unable to handle Home Monitoring system correctly
- Insufficient GSM coverage at patient's home
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Follow-up Schedule With Home Monitoring
The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).
Read the detailed description
Due to its integrated long-distance telemetry, the implantable pacemaker Philos II DR-T is capable of periodically transmitting data from the pacemaker memory to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the data and presents it to the physician on a password secured internet site. Additionally, in case certain event criteria are met, the most important Home Monitoring information are immediately faxed to the physician as an Event Report. These events can be customised by the physician. Thus, the physician will be able to closely monitor the patient and check the adequacy and efficiency of the pacemaker therapy without requiring the patient to visit the physician. The transmitted data comprise information on atrial and ventricular rhythm, atrioventricular conduction and system status.
The purpose of the national prospective, randomized, multicentric clinical study "COMPArative follow-up Schedule with home monitoring" (COMPAS) described here is to evaluate the benefits of pacemaker follow-up with home monitoring in France. The standard follow-up or therapeutic intervention will be deemed based on faxed event Reports reception and Cardio reports analysis on internet site. During the clinical study, the incidence of serious adverse events (hospitalisation, pacemaker dysfunction, and cardiovascular events), economic impact, safety, and practicability will be analysed. The findings from the ACTIVE group will be compared to those of a group receiving standard of care (CONTROL group). Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
The trial will be conducted as a prospective, randomised, open, multicenter, national clinical trial. The enrollment of 400 patients in 50 clinical centres in France is anticipated. The principal inclusion criterion is indication for dual chamber pacemaker/ICD implantation. Main exclusion criteria comprise pacemaker dependency.
- Conditions
- Pacemaker, Artificial, Bradycardia
- Being tested
- Home Monitoring
- Keywords
- Remote monitoring, Pacemaker, Follow up, Follow-up studies
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home MonitoringOther
Also called Remote monitoring
Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL group | Active comparator | The patients receive standard of care for 18 months. The CONTROL group patients will be equipped with Home Monitoring. However, the Home Monitoring data will not be used for patient surveillance; i. e. the patient will be followed in the conventional manner. Receives: Other: Home Monitoring |
| ACTIVE group | Experimental | The patients are followed by Home monitoring only. Every patient must be seen by his physician 18 months after enrolment for regular follow-up. Within this period, the additional Pace Maker follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception or patient/physician call Receives: Other: Home Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups
Measured: 18 months
Secondary outcomes (3)
Efficacy of Home Monitoring to detect pacemaker dysfunction
Measured: 18 months
Reduction of associated cost
Measured: 18 months
Delay of Home Monitoring to manage adverse events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionOct 2009
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 Pacemaker, ArtificialStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Investigators
- Philippe P MABO, Pr, Dr, Principal investigator, CHU Pontchaillou de Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989326
- Sponsor's protocol ID
- HS037
- Acronym
- COMPAS
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012 May;33(9):1105-11. doi: 10.1093/eurheartj/ehr419. Epub 2011 Nov 29.
PubMed 22127418
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Follow-up Schedule With Home Monitoring
- ClinicalTrials.gov ID
- NCT00989326
- Acronym / sponsor ID
- COMPAS / HS037
- Conditions
- Pacemaker, Artificial, Bradycardia
- Keywords
- Remote monitoring, Pacemaker, Follow up, Follow-up studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Biotronik FranceIndustry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Oct 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.
The study investigates whether home monitoring follow-up of Pace-Maker patients is as efficient as conventional method in terms of Significant Serious Adverse Event (SSAE).
Detailed description
Due to its integrated long-distance telemetry, the implantable pacemaker Philos II DR-T is capable of periodically transmitting data from the pacemaker memory to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the data and presents it to the physician on a password secured internet site. Additionally, in case certain event criteria are met, the most important Home Monitoring information are immediately faxed to the physician as an Event Report. These events can be customised by the physician. Thus, the physician will be able to closely monitor the patient and check the adequacy and efficiency of the pacemaker therapy without requiring the patient to visit the physician. The transmitted data comprise information on atrial and ventricular rhythm, atrioventricular conduction and system status.
The purpose of the national prospective, randomized, multicentric clinical study "COMPArative follow-up Schedule with home monitoring" (COMPAS) described here is to evaluate the benefits of pacemaker follow-up with home monitoring in France. The standard follow-up or therapeutic intervention will be deemed based on faxed event Reports reception and Cardio reports analysis on internet site. During the clinical study, the incidence of serious adverse events (hospitalisation, pacemaker dysfunction, and cardiovascular events), economic impact, safety, and practicability will be analysed. The findings from the ACTIVE group will be compared to those of a group receiving standard of care (CONTROL group). Both patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.
The trial will be conducted as a prospective, randomised, open, multicenter, national clinical trial. The enrollment of 400 patients in 50 clinical centres in France is anticipated. The principal inclusion criterion is indication for dual chamber pacemaker/ICD implantation. Main exclusion criteria comprise pacemaker dependency.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL group | Active comparator | Other: Home MonitoringThe patients receive standard of care for 18 months. The CONTROL group patients will be equipped with Home Monitoring. However, the Home Monitoring data will not be used for patient surveillance; i. e. the patient will be followed in the conventional manner. |
| ACTIVE group | Experimental | Other: Home MonitoringThe patients are followed by Home monitoring only. Every patient must be seen by his physician 18 months after enrolment for regular follow-up. Within this period, the additional Pace Maker follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception or patient/physician call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is willing and able to comply with the protocol
- The patient has provided written informed consent
- Patient whose medical situation is stable
- Patient with PHILOS II DR-T Pacemaker >= one month with A/V bipolar lead
- No change of residence expected during study
Key exclusion criteria (13 listed)
- Spontaneous Ventricular Rhythm < 30 ppm
- Heart failure no controlled by medical treatment
- Post cardiac surgery (< 1 month)
- Post myocardial infarction (< 1 month)
- More than two cardioversion shocks for last 6 month
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 MonitoringAlso: Remote monitoringBoth patient groups are followed for 18 months and will be followed with Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed. | Other | ACTIVE group, CONTROL group |
Primary outcome
Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups
Time frame: 18 months
3 secondary outcomes
Efficacy of Home Monitoring to detect pacemaker dysfunction
Time frame: 18 months
Reduction of associated cost
Time frame: 18 months
Delay of Home Monitoring to manage adverse events
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
- Derived from this study: PubMed 22127418Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012 May;33(9):1105-11. doi: 10.1093/eurheartj/ehr419. Epub 2011 Nov 29.
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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.
Philippe P MABO, Pr, Dr principal investigator
CHU Pontchaillou de Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Monitoring in people with Pacemaker, Artificial and Bradycardia, run by Biotronik France at 1 site in France.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 24 Jun 2010. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups (time frame: 18 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 NCT00989326, 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 24 Jun 2010.