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Remote Patient Management for Cardiac Implantable Electronic Devices

Cardiac Device | Rural

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.

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Participation Requirements

  • Sex:

    Male, Female, Intersex
  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

Saint John Regional Hospital
Saint John Regional Hospital
Saint John, New Brunswick
Canada

Contact Study Team

Southlake Regional Health Centre
Southlake Regional Health Centre
Newmarket, Ontario
Canada

Contact Study Team

Centre Hospitalier Universitaire de Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Canada

Contact Study Team

St. Boniface Hospital
St. Boniface Hospital
Winnipeg, Manitoba
Canada

Contact Study Team

London Health Sciences Center
London Health Sciences Center
London, Ontario
Canada

Contact Study Team

Hopital Laval
Hopital Laval
Québec, Quebec
Canada

Contact Study Team

Victoria Cardiac Arrhythmia Trials
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia
Canada

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Primary Contact

May Woodburn

[email protected]
250-595-0400
St. Mary's General Hospital
St. Mary's General Hospital
Kitchener, Ontario
Canada

Contact Study Team

Primary Contact

Mary Radyk

Hopital SacreCoeur
Hopital SacreCoeur
Montreal, Quebec
Canada

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Primary Contact

Ann Langlois

Foothills Hospital
Foothills Hospital
Calgary, Alberta
Canada

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Primary Contact

Marcello Tonelli

QEII HSC
QEII HSC
Halifax, Nova Scotia
Canada

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Primary Contact

Jennifer Thurlow

[email protected]
902 473-4841
Montreal Heart Institute
Montreal Heart Institute
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Jean-Claude Tardif

[email protected]
:514 376-3330
University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
Nova Scotia Health Authority
Participants Required
More Information
Study ID: NCT03405740