PacemakerPhase 4REMOTE-IPGNCT00631709
REmote MOnitoring Transmission Evaluation of IPGs
A Phase 4 study testing CareLink Remote Monitoring in people with Pacemaker, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in Canada.
Trial summary
The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up. Study Objectives include: 1. To determine clinician perceived quality of care for CareLink remote follow-up. 2. To determine patient satisfaction with CareLink follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker
- What is being tested?
- CareLink Remote Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2008to Feb 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads.
- Patients who have been implanted with their current pacemaker for at least 3 months.
- Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor.
- Patients who are willing and able to sign an IRB/MEC approved patient informed consent.
Who cannot join
- Patients participating in another study that would affect the objectives of this study
- Patients who have already previously used a Medtronic CareLink Monitor.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Kelowna General Hospital
Kelowna, British Columbia
Southlake Regional Hospital
Newmarket, Ontario
CHUQ, L'Hotel Dieu de Quebec
Québec, Quebec
About this study
The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up.
Study Objectives include:
Read more
- To determine clinician perceived quality of care for CareLink remote follow-up.
- To determine patient satisfaction with CareLink follow-up.
- To estimate the time required to perform patient follow-up via CareLink remote transmissions.
- To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
- To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
- To evaluate compliance to scheduled CareLink transmissions with the remote management system
This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months.
Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.
- Conditions
- Pacemaker
- Being tested
- CareLink Remote Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareLink Remote MonitoringOther
Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pacemaker Patients Receives: Other: CareLink Remote Monitoring |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631709
- Sponsor's protocol ID
- REMOTE-IPG 2008
- Acronym
- REMOTE-IPG
- Status last verified
- Apr 2018
- First submitted
- 3 Mar 2008
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote MOnitoring Transmission Evaluation of IPGs
- ClinicalTrials.gov ID
- NCT00631709
- Acronym / sponsor ID
- REMOTE-IPG / REMOTE-IPG 2008
- Conditions
- Pacemaker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Mar 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 evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up.
Study Objectives include:
- To determine clinician perceived quality of care for CareLink remote follow-up.
- To determine patient satisfaction with CareLink follow-up.
- To estimate the time required to perform patient follow-up via CareLink remote transmissions.
- To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
- To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
- To evaluate compliance to scheduled CareLink transmissions with the remote management system
This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months.
Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: CareLink Remote MonitoringPacemaker Patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads.
- Patients who have been implanted with their current pacemaker for at least 3 months.
- Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor.
- Patients who are willing and able to sign an IRB/MEC approved patient informed consent.
Key exclusion criteria (2 listed)
- Patients participating in another study that would affect the objectives of this study
- Patients who have already previously used a Medtronic CareLink Monitor.
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 |
|---|---|---|
| CareLink Remote MonitoringSubstitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits | Other | 1 |
Primary outcome
Not reported in the source record.
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 26 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CareLink Remote Monitoring in people with Pacemaker, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in Canada.
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 4 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: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 26 Apr 2018.