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| Name | Class |
|---|---|
| Cardiac Arrhythmia Network of Canada | OTHER |
| Abbott Medical Devices | INDUSTRY |
| Medtronic | INDUSTRY |
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This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.
Remote monitoring (RM) has been in use for over a decade and is now used in a blended system of in clinic visits and RM to provide CIED follow up. Prior studies have focused on this blended model of follow up. In this study, we propose a paradigm shift in CIED follow up care that is fully remote, supported by a patient-centered communication system permitting patients to have greater understanding of their CIED and its function. Patients would not have to leave their own communities to obtain state-of-the art care for their cardiac condition or their CIED. Given the burgeoning use of CIEDs (ICDs and PMs), the aging population and particularly in Canada where 19% of the inhabitants are in communities classified as 'rural', many have long distances to travel to reach a health care facility, it is of the utmost importance to take full advantage of available and developing technologies to improve CIED follow up beyond current recommendations. 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. New technology has become available that not only permits surveillance, but also permits communication back to the patient, and their respective providers regarding the status of these devices. The combination of technologies will result in a total care of CIEDs termed Remote Patient Management - CIED (RPM-CIED). The incorporation of enhanced monitoring 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 ('spokes') and no longer require travel to the specialized device clinics ('hubs') for follow-up. It creates capacity in the specialized centers to focus exclusively on the problematic cases by removing the need for routine checks.
There are two avenues of new technology that will be used in this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Patient Management | Active Comparator | Patients will be followed by remote monitoring only. |
|
| Standard of Care | Placebo Comparator | Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Patient Management | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to major adverse cardiac event (primary safety outcome) | Time to a major adverse event, including: death, stroke, hospitalization for complications relating to the device system, cardiovascular hospitalization, syncope, device-related Emergency Department visits. | 18 months |
| Time to a device-detected event (primary efficacy outcome) | The response time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues with remote patient management as compared to standard of care | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Compliance | Compliance will be measured according to current Canadian Cardiovascular Society Heart Failure Guidelines | 18 Months |
| Minimum programming compliance | Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ratika Parkash, MD FRCPC | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Hospital | Calgary | Alberta | Canada | |||
| Victoria Cardiac Arrhythmia Trials |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard of Care | Device | No intervention |
|
| 18 months |
| Number of clinical events leading to a change in medication | Events detected by the ICD that lead to a clinical decision to change medication | 18 months |
| Inappropriate ICD shocks | Number of inappropriate ICD shocks | 18 months |
| Appropriate ICD shocks | Number of appropriate ICD shocks | 18 months |
| Time to detection of ventricular arrhythmia events | device-detected ventricular fibrillation or ventricular tachycardia | 18 months |
| Detection of atrial high-rate episodes | Device detected high-rate episodes greater than 6 minutes | 18 months |
| Number of Cardiovascular-related ER visits | Number of cardiovascular-related visits (<24 hours) | 18 months |
| Number of Device-Related ER visits | ER visits (<24 hrs) for a device-related reason (including an audio signal from the device (beeping), shock(s), or a device complication requiring medical attention) | 18 Months |
| Rate of syncope | Syncope | 18 months |
| Cost effectiveness | An economic evaluation will include a cost utility analysis | 18 months |
| Victoria |
| British Columbia |
| V8Z 0B9 |
| Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | Canada |
| QEII HSC | Halifax | Nova Scotia | B3H 3A7 | Canada |
| St. Mary's General Hospital | Kitchener | Ontario | Canada |
| London Health Sciences Center | London | Ontario | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P6 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Hopital SacreCoeur | Montreal | Quebec | Canada |
| Hopital Laval | Québec | Quebec | G1V 4G5 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |