Remote Patient Management of CIEDs (RPM CIED Tachy)

• ClinicalTrials.gov Identifier: NCT03405740
• Recruitment Status: Recruiting
• First Posted: January 23, 2018
• Last Update Posted: March 11, 2022
• Sponsor: Ratika Parkash
• Collaborator: Cardiac Arrhythmia Network of Canada
• Information provided by (Responsible Party): Ratika Parkash, Nova Scotia Health Authority

Tracking Information

• First Submitted Date: January 15, 2018
• First Posted Date: January 23, 2018
• Last Update Posted Date: March 11, 2022
• Actual Study Start Date: May 1, 2020
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Remote Patient Management of CIEDs
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cardiac Arrhythmia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 15, 2018): 2554
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Canada

Administrative Information

• NCT Number: NCT03405740
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Ratika Parkash, Nova Scotia Health Authority
• Original Responsible Party: Same as current
• Current Study Sponsor: Ratika Parkash
• Original Study Sponsor: Nova Scotia Health Authority
• Collaborators: Cardiac Arrhythmia Network of Canada

Investigators

• Principal Investigator: Ratika Parkash, MD FRCPC; Nova Scotia Health Authority

• PRS Account: Nova Scotia Health Authority
• Verification Date: March 2022