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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 : Recruiting
First Posted : January 23, 2018
Last Update Posted : March 11, 2022
Sponsor:
Collaborator:
Cardiac Arrhythmia Network of Canada
Information provided by (Responsible Party):
Ratika Parkash, Nova Scotia Health Authority

Study Description
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Brief Summary:
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Device: Remote Patient Management Device: Standard of Care Not Applicable

Detailed Description:

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:

  1. 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).
  2. 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Remote Patient Management
Patients will be followed by remote monitoring only.
 Device: Remote Patient Management
  1. Transmissions will occur at six monthly intervals, with no in-clinic visits. If there is an actionable event on the remote transmission, patients will be seen at their closest community clinic.
  2. All patients will be required to follow up with their family physician at least annually, and their cardiologist at least every 2 years.
  3. Patients will be contacted by phone at 6 months and 12 months to document their current health status (change in cardiovascular medications, any cardiovascular hospitalizations, in-clinic device checks, or any new cardiovascular testing completed since the last visit)
  4. VIRTUES access
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
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Time to detection of ventricular arrhythmia events [ Time Frame: 18 months ]
    device-detected ventricular fibrillation or ventricular tachycardia

  2. Detection of atrial fibrillation episodes [ Time Frame: 18 months ]
    Device detected episodes of atrial fibrillation

  3. Atrial fibrillation related hospitalizations [ Time Frame: 18 months ]
    Hospitalization with a primary diagnosis of atrial fibrillation

  4. Time to syncope [ Time Frame: 18 months ]
    Syncope

  5. Cost effectiveness [ Time Frame: 18 months ]
    An economic evaluation will include a cost utility analysis


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medtronic or Abbott defibrillator (ICD or CRT-D) capable of remote monitoring with Carelink/Merlin
  • Able to provide consent

Exclusion Criteria:

  • No family physician
  • Inability to be referred to a specialist
  • Currently followed more than every 6 months by a Heart Function Clinic
  • Participation in another randomized clinical trial
  • Unreliable autocapture by device in pacemaker dependent patient
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ratika Parkash, MD FRCPC 902 473 4474 ratika.parkash@nshealth.ca
Contact: Karen Giddens 902 473 2758 karen.giddens@nshealth.ca

Locations
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Canada, Alberta
Foothills Hospital Recruiting
Calgary, Alberta, Canada
Contact: Marcello Tonelli         
Principal Investigator: Satish Raj, MD, FRCPC         
Canada, Manitoba
St. Boniface Hospital Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Rebecca Fromm         
Principal Investigator: Clarence Khoo, MD, FRCPC         
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada
Contact: Jessica Gallager         
Principal Investigator: Satish Toal, MBBS, FRCPC         
Canada, Nova Scotia
QEII HSC Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Jennifer Thurlow    902 473-4841    jennifer.thurlow@nshealth.ca   
Principal Investigator: Amir AbdelWahab, MBBCh MSc MD         
Canada, Ontario
St. Mary's General Hospital Recruiting
Kitchener, Ontario, Canada
Contact: Mary Radyk         
Principal Investigator: Umjeet Jolly, MD, FRCPC         
London Health Sciences Center Not yet recruiting
London, Ontario, Canada
Contact: Cheryl Litchfield         
Principal Investigator: Anthony Tang, MD, FRCPC         
Canada, Quebec
Hopital SacreCoeur Recruiting
Montreal, Quebec, Canada
Contact: Ann Langlois         
Principal Investigator: Marcio Sturmer, MD, FRCPC         
Hopital Laval Recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Paule Banville    418-656-8711 ext : 2132    paule.banville@criucpq.ulaval.ca   
Principal Investigator: Isabelle Nault, MD FRCPC         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Stephanie McMahon    1 844 721-6094      
Principal Investigator: Felix Ayala-Paredes, MD         
Sponsors and Collaborators
Ratika Parkash
Cardiac Arrhythmia Network of Canada
Investigators
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Principal Investigator: Ratika Parkash, MD FRCPC Nova Scotia Health Authority
More Information
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Responsible Party: Ratika Parkash, Staff Electrophysiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03405740    
Other Study ID Numbers: RP005
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes