RPM CIED Tachy: Remote Patient Management of CIEDs

• Sponsor: Ratika Parkash (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03405740
• Collaborator: Cardiac Arrhythmia Network of Canada (Other)
• Enrollment: 2,554
• Locations: 9
• Arms: 2
• Anticipated Duration (Months): 34
• Patients Per Site: 283.8
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remote Patient Management Patients will be followed by remote monitoring only.	Device: Remote Patient Management; 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. All patients will be required to follow up with their family physician at least annually, and their cardiologist at least every 2 years. 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) 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

Primary Outcome Measures

1. Time to major adverse cardiac event (primary safety outcome) [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 [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 [18 months]

   device-detected ventricular fibrillation or ventricular tachycardia

2. Detection of atrial fibrillation episodes [18 months]

   Device detected episodes of atrial fibrillation

3. Atrial fibrillation related hospitalizations [18 months]

   Hospitalization with a primary diagnosis of atrial fibrillation

4. Time to syncope [18 months]

   Syncope

5. Cost effectiveness [18 months]

   An economic evaluation will include a cost utility analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Foothills Hospital	Calgary	Alberta	Canada
2	St. Boniface Hospital	Winnipeg	Manitoba	Canada
3	Saint John Regional Hospital	Saint John	New Brunswick	Canada
4	QEII HSC	Halifax	Nova Scotia	Canada	B3H 3A7
5	St. Mary's General Hospital	Kitchener	Ontario	Canada
6	London Health Sciences Center	London	Ontario	Canada
7	Hopital SacreCoeur	Montreal	Quebec	Canada
8	Hopital Laval	Québec	Quebec	Canada	G1V 4G5
9	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4

Sponsors and Collaborators

• Ratika Parkash
• Cardiac Arrhythmia Network of Canada

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ratika Parkash, Staff Electrophysiologist, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT03405740
• Other Study ID Numbers: RP005
• First Posted: Jan 23, 2018
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Mar 11, 2022