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Device

Remote Monitoring for Pacemaker Management (RPM CIED Brady 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

RPM CIED Brady Trial Summary

This trial is designed to evaluate the use of remote monitoring for pacemaker patients in Canada.

Who is the study for?

This trial is for patients with a Medtronic or Abbott pacemaker that can be remotely monitored. Participants must be able to give consent and have access to a smartphone or tablet. It's not for those without a family doctor or if their device doesn't reliably adjust pacing in pacemaker-dependent patients.Check my eligibility

What is being tested?

The study is testing the effectiveness of remote monitoring (RM) technology for managing cardiac implantable electronic devices (CIEDs), specifically pacemakers, compared to standard care. The goal is to follow up safely and cost-effectively using CANet's patient-centered platform.See study design

What are the potential side effects?

Since this trial involves non-invasive remote monitoring rather than medication, traditional side effects are not expected. However, there may be risks related to data privacy, reliance on technology, and potential delays in emergency response.

RPM CIED Brady Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cost effectiveness

Time to major adverse cardiac event (primary safety outcome)

Secondary outcome measures

Quality of Life - Brief Illness Perception Questionnaire (BIPQ)

Quality of Life - Florida Patient Acceptance Survey (FPAS)

Quality of Life - Florida Shock Anxiety Scale (FSAS)

+1 more

RPM CIED Brady Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Remote Patient ManagementActive Control1 Intervention

Remote monitoring only

Group II: Standard of CarePlacebo Group1 Intervention

In-clinic visits

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ratika ParkashLead Sponsor

4 Previous Clinical Trials

2,957 Total Patients Enrolled

Ratika Parkash, MD FRCPCPrincipal InvestigatorNova Scotia Health Authority

2 Previous Clinical Trials

2,648 Total Patients Enrolled

Media Library

Remote Monitoring (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03636230 — N/A

Pacemaker Research Study Groups: Remote Patient Management, Standard of Care

Pacemaker Clinical Trial 2023: Remote Monitoring Highlights & Side Effects. Trial Name: NCT03636230 — N/A

Remote Monitoring (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03636230 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this trial currently available for participants?

"As per the data on clinicaltrials.gov, recruitment for this study is still ongoing; it was first posted on September 15th 2020 and most recently updated on July 19th 2022."

Answered by AI

In what geographical locations is this experiment operational?

"Currently, this medical research initiative is recruiting from 5 sites; 3 within Canada and 2 abroad. To reduce travel hardship for those who participate in the trial, it is important to choose a location closest to you. These locations are Montréal, Kitchener, Halifax as well as two other undisclosed cities."

Answered by AI

What is the current cohort size for this clinical experiment?

"Affirmative. Clinicaltrials.gov's information indicates that this research is open to recruitment, having been posted on September 15th 2020 and updated on July 19th 2022. 848 patients are needed from 5 different clinical sites."

Answered by AI

What outcome is this clinical trial striving to realize?

"This 18-month trial seeks to evaluate the cost efficiency of this intervention. Secondary objectives include assessing Quality of Life through three distinct surveys: The SF-36, FPAS and BIPQ. Responses on these measure patient vitality, physical functioning, bodily pain and mental health in order to produce individual scores that range from 0-100 or 0-10 depending on the survey used."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote Patient Management of CIEDs - Brady Devices

Ratika Parkash 2020. "Remote Patient Management of CIEDs - Brady Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03636230.