Remote Patient Management of CIEDs (RPM CIED Tachy)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03405740|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : March 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrhythmia||Device: Remote Patient Management Device: Standard of Care||Not Applicable|
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:
- Remote View: this secure, web-based portal facilitates a virtual view of the device programming by the specialist in real-time while the patient is in their local clinic, thus avoiding patient travel to the specialized clinic (hub).
- VIRTUES (Virtual Integrated Reliable Transformative User-driven E-health System): this portal has been developed by the Cardiac Arrhythmia Network of Canada to allow the patient to receive reports from the remote transmissions of their device.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2554 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy|
|Estimated Study Start Date :||July 6, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 2022|
Active Comparator: Remote Patient Management
Patients will be followed by remote monitoring only.
Device: Remote Patient Management
Placebo Comparator: Standard of Care
Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.
Device: Standard of Care
- Time to major adverse cardiac event (primary safety outcome) [ Time Frame: 18 months ]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.
- Time to a device-detected event [ Time Frame: 18 months ]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
- Time to detection of ventricular arrhythmia events [ Time Frame: 18 months ]device-detected ventricular fibrillation or ventricular tachycardia
- Detection of atrial fibrillation episodes [ Time Frame: 18 months ]Device detected episodes of atrial fibrillation
- Atrial fibrillation related hospitalizations [ Time Frame: 18 months ]Hospitalization with a primary diagnosis of atrial fibrillation
- Time to syncope [ Time Frame: 18 months ]Syncope
- Cost effectiveness [ Time Frame: 18 months ]An economic evaluation will include a cost utility analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405740
|Contact: Ratika Parkash, MD FRCPC||902 473 email@example.com|
|Contact: Karen Giddens||902 473 firstname.lastname@example.org|
|Principal Investigator:||Ratika Parkash, MD FRCPC||Nova Scotia Health Authority|