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Behavioural Intervention

Remote Patient Management for Cardiac Arrhythmias (RPM CIED Tachy Trial)

N/A
Recruiting
Led By Ratika Parkash, MD FRCPC
Research Sponsored by Ratika Parkash
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Currently followed more than every 6 months by a Heart Function Clinic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months

Summary

This trial will compare remote patient management to usual care, and will focus on whether or not the RemoteView system is used.

Who is the study for?
This trial is for individuals who can consent and have a specific Medtronic or Abbott defibrillator that supports remote monitoring. They must have a family physician and not be part of another clinical trial. It's not for those needing frequent heart clinic visits or with unreliable pacemaker function.
What is being tested?
The study compares two approaches to managing cardiac arrhythmias: one group will use remote patient management tools, while the other will receive usual care without these tools. Participants are randomly assigned to groups, considering their current tech use and location.
What are the potential side effects?
Since this trial involves management methods rather than medication, traditional side effects aren't expected. However, there may be risks related to data privacy, reliance on technology for health monitoring, and potential delays in emergency response.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I visit a Heart Function Clinic more than twice a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to a device-detected event
Time to major adverse cardiac event (primary safety outcome)
Secondary study objectives
Atrial fibrillation related hospitalizations
Cost effectiveness
Detection of atrial fibrillation episodes
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Remote Patient ManagementActive Control1 Intervention
Patients will be followed by remote monitoring only.
Group II: Standard of CarePlacebo Group1 Intervention
Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.

Find a Location

Who is running the clinical trial?

Ratika ParkashLead Sponsor
4 Previous Clinical Trials
1,251 Total Patients Enrolled
Cardiac Arrhythmia Network of CanadaOTHER
11 Previous Clinical Trials
5,115 Total Patients Enrolled
Ratika Parkash, MD FRCPCPrincipal InvestigatorNova Scotia Health Authority
2 Previous Clinical Trials
942 Total Patients Enrolled

Media Library

Remote Patient Management (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03405740 — N/A
Arrhythmia Research Study Groups: Remote Patient Management, Standard of Care
Arrhythmia Clinical Trial 2023: Remote Patient Management Highlights & Side Effects. Trial Name: NCT03405740 — N/A
Remote Patient Management (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03405740 — N/A
~46 spots leftby Dec 2024
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