NCT03405740

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,115

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
May 2020Jun 2026

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2.3 years until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

January 15, 2018

Last Update Submit

February 12, 2026

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (2)

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

    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.

    18 months

  • Time to a device-detected event (primary efficacy outcome)

    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

    18 months

Secondary Outcomes (11)

  • Medication Compliance

    18 Months

  • Minimum programming compliance

    18 months

  • Number of clinical events leading to a change in medication

    18 months

  • Inappropriate ICD shocks

    18 months

  • Appropriate ICD shocks

    18 months

  • +6 more secondary outcomes

Study Arms (2)

Remote Patient Management

ACTIVE COMPARATOR

Patients will be followed by remote monitoring only.

Device: Remote Patient Management

Standard of Care

PLACEBO COMPARATOR

Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.

Device: Standard of Care

Interventions

Remote Patient ManagementDEVICE

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

Remote Patient Management
Standard of CareDEVICE

No intervention

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a Medtronic, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
  • Able to provide consent.
  • Age \>/= 18 years

You may not qualify if:

  • No family physician or general practitioner
  • 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 that impacts outcome
  • Unreliable automated capture verification by device in pacemaker dependent patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Foothills Hospital

Calgary, Alberta, Canada

Location

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8Z 0B9, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Location

QEII HSC

Halifax, Nova Scotia, B3H 3A7, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, Canada

Location

London Health Sciences Center

London, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P6, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hopital SacreCoeur

Montreal, Quebec, Canada

Location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ratika Parkash, MD FRCPC

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

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 Electrophysiologist

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

May 1, 2020

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(12)