Remote management of heart devices

Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy

This study is testing if remote monitoring of heart devices can help patients manage their care better without needing to travel to the doctor, especially for those living in rural areas.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1164 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nova Scotia Health Authority (Academic / other)
• Locations: 12 sites (Calgary, Alberta and 11 other locations)
• Trial ID: NCT03405740 on ClinicalTrials.gov

What this trial studies

This Canadian multicenter randomized controlled trial evaluates the effectiveness of fully remote patient management for individuals with cardiac implantable electronic devices (CIEDs) compared to standard care. Patients will be randomized to receive either remote monitoring through the VIRTUES system or usual care, with stratification based on the use of RemoteView technology. The study aims to enhance patient understanding of their devices and reduce the need for travel to healthcare facilities, particularly benefiting those in rural areas. By leveraging new communication technologies, the trial seeks to improve follow-up care for patients with CIEDs, addressing potential complications and enhancing overall patient management.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a Medtronic, Abbott, or Boston Scientific defibrillator or CRT-D capable of remote monitoring.

Not a fit: Patients without a family physician or those currently followed more frequently than every six months by a Heart Function Clinic may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve access to care and patient outcomes for those with cardiac devices.

How similar studies have performed: Previous studies have shown promise in blended remote monitoring models, but this fully remote approach represents a novel shift in CIED follow-up care.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. No family physician or general practitioner
2. Inability to be referred to a specialist
3. Currently followed more than every 6 months by a Heart Function Clinic
4. Participation in another randomized clinical trial that impacts outcome
5. Unreliable automated capture verification by device in pacemaker dependent patient

Where this trial is running

Calgary, Alberta and 11 other locations

• Foothills Hospital — Calgary, Alberta, Canada (Recruiting)
• Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada (Recruiting)
• St. Boniface Hospital — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
• Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)
• Qeii Hsc — Halifax, Nova Scotia, Canada (Recruiting)
• St. Mary's General Hospital — Kitchener, Ontario, Canada (Recruiting)
• London Health Sciences Center — London, Ontario, Canada (Not_yet_recruiting)
• Southlake Regional Health Centre — Newmarket, Ontario, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Hopital SacreCoeur — Montreal, Quebec, Canada (Recruiting)
• Hopital Laval — Québec, Quebec, Canada (Recruiting)
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Ratika Parkash, MD FRCPC — Nova Scotia Health Authority
• Study coordinator: Ratika Parkash, MD FRCPC

Conditions Cardiac Arrhythmia