Remote Patient Management of CIEDs - Brady Devices

NCT03636230 | Recruiting

• 1 other identifier: RP-006
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Pacemaker

Outcome Measures

Primary Outcomes (2)

• Time to major adverse cardiac event (primary safety outcome)

  Time to major adverse events (death, stroke, hospitalization for a cardiovascular cause, syncope or device-related emergency department visits). Survival free from the primary outcome will be estimated by the Kaplan-Meier method and compared, using the log-rank test. Cox proportional hazard regression analysis will be used to estimate the likelihood of survival, after verifying the proportional hazard assumption.

  18 months

• Cost effectiveness

  Analysis will take the form of a cost utility analysis with cost effectiveness assessed in terms of the incremental cost per quality life year (QALY). Analysis will incorporate data on resource use and patient's utility values for the period from initiation of remote patient management to 12 months follow-up. Resource use associated with the remote patient management strategy will be estimated through detailed microcosting and will be contrasted with the costs of standard monitoring. QALYs will be estimated using the standard area under the cover methodology, controlling for baseline utility. Total costs and QALYs for each patient will be estimated with multiple imputation for missing data. The incremental costs and QALYs and incremental cost effectiveness ratios associated with remote patient management and the uncertainty around these will be derived through non-parametric bootstrapping.

  18 months

Secondary Outcomes (8)

• Quality of Life - Short Form (SF36)

  18 months

• Quality of Life - Florida Patient Acceptance Survey (FPAS)

  18 months

• Quality of Life - Florida Shock Anxiety Scale (FSAS)

  18 months

• Quality of Life - Brief Illness Perception Questionnaire (BIPQ)

  18 months

• Device-related ER visits

  18 months

Study Arms (2)

Remote Patient Management

ACTIVE COMPARATOR

Remote monitoring only

Device: Remote Monitoring

Standard of Care

PLACEBO COMPARATOR

In-clinic visits

Other: Standard of care

Interventions

Remote Monitoring DEVICE

Remote Monitoring only + VIRTUES

Remote Patient Management

Standard of care OTHER

In-Clinic visits only

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ratika Parkash: lead
• Cardiac Arrhythmia Network of Canada: collaborator
• Medtronic: collaborator
• Abbott: collaborator

Study Sites (11)

Foothills Hospital

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8T 1Z8, Canada

RECRUITING

Memorial University of Newfoundland Hospital

St. John's, Newfoundland and Labrador, Canada

RECRUITING

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

St. Mary's General Hospital

Kitchener, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W5, Canada

RECRUITING

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Hopital Sacre Coeur

Montreal, Quebec, Canada

RECRUITING

Hopital Laval

Québec, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire du Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ratika Parkash, MD FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ratika Parkash, MD FRCPC

CONTACT

902 473 4474; ratika.parkash@nshealth.ca

Patricia Theoret

CONTACT

613-866-0698; patricia.theoret-patrick@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Cardiologist Electrophysiologist

Model Details: Open label, 1:1 randomized trial, stratified by site and pacemaker dependence

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: August 17, 2018
• Study Start: September 15, 2020
• Primary Completion: February 28, 2025
• Study Completion: June 30, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)