RecruitingNot ApplicableNCT03636230

Remote Patient Management of CIEDs - Brady Devices

Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices


Sponsor

Ratika Parkash

Enrollment

848 participants

Start Date

Sep 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000 patients with cardiac implantable electronic devices (CIEDs) are enrolled in this program. This technology is in widespread use worldwide for all CIEDs but in Canada, it is utilized primarily for implantable defibrillators, but not pacemakers. Whereas most of the trials were designed to evaluate the efficacy of RM in implantable cardioverter defibrillator (ICD) patients, in the pacemaker (PM) population, there has been work performed already to demonstrate an increase in detection of frequency of adverse clinical events and a reduction in reaction time to those events by RM. Based on all the available literature, it appears that RM benefits both patients and healthcare systems. Overall, studies have demonstrated that RM can be used safely in all device patient-populations, with the exception of pacemaker-dependent patients. There have been no studies that have evaluated RM only follow up, nor have there been any studies evaluating pacemaker-dependent patients. This study that will safely assess the use of RM only, with in-clinic visits when necessary, that uses the patient-centered electronic platform developed by the Cardiac Arrhythmia Network of Canada (CANet) to perform PM follow up safely, in a more cost-effective manner.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
  • Able to provide consent.
  • Age >/= 18 years

Exclusion Criteria3

  • No access to a family physician or general practioner
  • Participation in the RPM CIED pilot study
  • Unreliable automated capture verification function by the device in pacemaker-dependent patients

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Interventions

DEVICERemote Monitoring

Remote Monitoring only + VIRTUES

OTHERStandard of care

In-Clinic visits only


Locations(11)

Foothills Hospital

Calgary, Alberta, Canada

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Memorial University of Newfoundland Hospital

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

St. Mary's General Hospital

Kitchener, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Hopital Sacre Coeur

Montreal, Quebec, Canada

Hopital Laval

Québec, Quebec, Canada

Centre Hospitalier Universitaire du Sherbrooke

Sherbrooke, Quebec, Canada

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NCT03636230


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