Remote Patient Management for Cardiac Implantable Electronic Devices
Summary
NOTE: To participate in this study, you must have a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) that is capable of remote monitoring.
Remote monitoring is in widespread use worldwide, but in Canada, it is used primarily in patients with ICDs, not pacemakers. It is cost-effective and can reduce the detection times of potential cardiac problems.
What is Remote Monitoring Technology?
The remote monitoring technology will communicate with your implantable device using wireless technology. It sends the information from your pacemaker to an application on your phone. That application sends the same information through the internet to the device clinic, reducing the need for frequent in-clinic visits. You will need access to a smartphone or tablet in order for this technology to work.
How is the Study Being Done?
Participants in this study will be randomly placed in one of two groups. Neither you, the study staff nor the investigator(s) can influence which group you are in. You will have a 50 % chance of being placed in either the remote management group (RPM) or the standard of care group (SOC). You and the research team will know which group you are in. In the RPM group, you will test out a new remote monitoring application, called VIRTUES, and only do remote transmissions for the duration of the study. In the SOC group, your care will be unaffected and you will simply be followed by our research team. The length of this study for each participant is 18 months.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 120
Inclusion criteria:
PACEMAKER:
1. Patients with a pacemaker capable of remote patient management OR de novo Abbott pacemaker (Assurity or newer model) within 8 weeks of screening.
2. Able to provide consent.
3. Age >/= 18 years
ICD:
1. Patients with a Medtronic, Abbott, or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin, or Latitude.
2. Able to provide consent.
3. Age >/= 18 years
Exclusion criteria:
1. No family physician or general practitioner
2. Inability to be referred to a specialist
3. Participation in the RPM CIED Pilot study
4. Currently followed > 6 months by a Heart Function Clinic
5. Participation in another randomization clinic trial that impacts outcome
6. Unreliable automated capture verification by device in pacemaker dependent patients
Participate
Additional information
Contact information
Recruitment for this study takes place through the Cardiac Implantable Electrical Device (CIED) located at Foothills Medical Centre and South Health Campus. When attending a visit at either of these locations, please feel free to bring up your interest in the Remote Monitoring Study to your device clinic nurse.
Principal investigator:
Satish Raj
Clinical trial:
Yes
REB-ID:
REB18-1363