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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
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 moreTrial 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.
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Who is running the clinical trial?
Ratika ParkashLead Sponsor
4 Previous Clinical Trials
1,251 Total Patients Enrolled
Cardiac Arrhythmia Network of CanadaOTHER
12 Previous Clinical Trials
5,785 Total Patients Enrolled
Ratika Parkash, MD FRCPCPrincipal InvestigatorNova Scotia Health Authority
2 Previous Clinical Trials
942 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The device that helps your heart beat cannot be trusted to work properly on its own.You cannot be sent to a specialist for further evaluation.You have a specific type of defibrillator from Medtronic or Abbott that can be monitored remotely using Carelink or Merlin.I visit a Heart Function Clinic more than twice a year.
Research Study Groups:
This trial has the following groups:- Group 1: Remote Patient Management
- Group 2: Standard of Care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.