Arrhythmia, CardiacRPM-CIEDNCT02585817
Remote Patient Management for Cardiac Implantable Electronic Devices
A study testing Remote CIED Management in people with Arrhythmia, Cardiac, run by Ratika Parkash at 1 site in Canada.
Trial summary
This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Cardiac
- What is being tested?
- Remote CIED Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Apr 2019
- 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
- Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities.
- Able to provide consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study
This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:
- Long, expensive travel for patients
- Morbidity to patients due to delay in receiving appropriate treatment
- Efficiency in health care delivery
- Patient satisfaction
Read the detailed description
Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated.
While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.
- Conditions
- Arrhythmia, Cardiac
- Being tested
- Remote CIED Management
- Keywords
- Cardiac Implantable Electronic Devices
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote CIED ManagementDevice
Information Technology
| Study group | Role | What they receive |
|---|---|---|
| Remote CIED Management | Experimental | Patients with a CIED will undergo remote monitoring with information technology. Receives: Device: Remote CIED Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.
Measured: 6 months
Secondary outcomes (2)
Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers
Measured: 6 months
Compliance (number of received remote transmissions divided by the number of expected remote transmissions)
Compliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2016
- Primary completionMar 2019
- Study completionApr 2019
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 Arrhythmia, CardiacStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratika Parkash
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada, Medtronic
- Responsible party
- Sponsor-investigator, Ratika Parkash, Nova Scotia Health Authority
- Investigators
- Ratika Parkash, MD, FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585817
- Sponsor's protocol ID
- RP-002
- Acronym
- RPM-CIED
- Status last verified
- Apr 2019
- First submitted
- 16 Oct 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sapp JA, Gillis AM, AbdelWahab A, Nault I, Nery PB, Healey JS, Raj SR, Lockwood E, Sterns LD, Sears SF, Wells GA, Yee R, Philippon F, Tang A, Parkash R. Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study. CMAJ Open. 2021 Jan 25;9(1):E53-E61. doi: 10.9778/cmajo.20200041. Print 2021 Jan-Mar.
PubMed 33495385
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study
- ClinicalTrials.gov ID
- NCT02585817
- Acronym / sponsor ID
- RPM-CIED / RP-002
- Conditions
- Arrhythmia, Cardiac
- Keywords
- Cardiac Implantable Electronic Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Ratika ParkashUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada, Medtronic
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 23 Oct 2015 (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.
This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:
- Long, expensive travel for patients
- Morbidity to patients due to delay in receiving appropriate treatment
- Efficiency in health care delivery
- Patient satisfaction
Detailed description
Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated.
While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote CIED Management | Experimental | Device: Remote CIED ManagementPatients with a CIED will undergo remote monitoring with information technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities.
- Able to provide consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Remote CIED ManagementInformation Technology | Device | Remote CIED Management |
Primary outcome
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.
Time frame: 6 months
2 secondary outcomes
Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers
Time frame: 6 months
Compliance (number of received remote transmissions divided by the number of expected remote transmissions)
Time frame: 12 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 25 Apr 2019.
- Derived from this study: PubMed 33495385Sapp JA, Gillis AM, AbdelWahab A, Nault I, Nery PB, Healey JS, Raj SR, Lockwood E, Sterns LD, Sears SF, Wells GA, Yee R, Philippon F, Tang A, Parkash R. Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study. CMAJ Open. 2021 Jan 25;9(1):E53-E61. doi: 10.9778/cmajo.20200041. Print 2021 Jan-Mar.
- Individual participant dataSharing planned: No
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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.
Ratika Parkash, MD, FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote CIED Management in people with Arrhythmia, Cardiac, run by Ratika Parkash at 1 site 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 2 inclusion and 0 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 25 Apr 2019. 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 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.
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?
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients. (time frame: 6 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 NCT02585817, 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 25 Apr 2019.