We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 15, 2018
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date March 11, 2022
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • Time to a clinical 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
  • Safety [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • Time to detection of ventricular arrhythmia events [ Time Frame: 18 months ]
  • Detection of atrial fibrillation episodes [ Time Frame: 18 months ]
  • Atrial fibrillation related hospitalizations [ Time Frame: 18 months ]
  • Rate of syncope [ Time Frame: 18 months ]
  • Cost effectiveness [ Time Frame: 18 months ]
    An economic evaluation will include a cost utility analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Patient Management of CIEDs
Official Title  ICMJE Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrhythmia
Intervention  ICMJE
  • 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
  • Device: Standard of Care
    No intervention
Study Arms  ICMJE
  • Active Comparator: Remote Patient Management
    Patients will be followed by remote monitoring only.
    Intervention: 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.
    Intervention: Device: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2018)
2554
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ratika Parkash, MD FRCPC 902 473 4474 ratika.parkash@nshealth.ca
Contact: Karen Giddens 902 473 2758 karen.giddens@nshealth.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03405740
Other Study ID Numbers  ICMJE RP005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ratika Parkash, Nova Scotia Health Authority
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ratika Parkash
Original Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE Cardiac Arrhythmia Network of Canada
Investigators  ICMJE
Principal Investigator: Ratika Parkash, MD FRCPC Nova Scotia Health Authority
PRS Account Nova Scotia Health Authority
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP