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Cardiac Monitoring System for Arrhythmia in Hemodialysis Patients

N/A

Waitlist Available

Led By Christopher W McIntyre, MD

Research Sponsored by Lawson Health Research Institute

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 through heart monitoring of 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to understand why dialysis patients have high rates of cardiac death, & use an implantable device to monitor heart rhythms & ultrasound/x-ray scans to compare a predictive model.

Who is the study for?

This trial is for adults over 18 who've been on hemodialysis for kidney failure for at least 3 months and produce less than 250ml of urine per day. They must be able to consent to the study. It's not open to those with pacemakers, defibrillators, a history of chronic arrhythmia, or those taking anti-arrhythmic drugs.

What is being tested?

The trial is testing an implantable heart rhythm monitor called Reveal LINQ in dialysis patients. The device will track heart rhythms to investigate the link between dialysis treatment and cardiac injuries that can lead to sudden death.

What are the potential side effects?

Potential side effects may include discomfort or complications from the device implantation procedure, such as infection or bleeding at the site where it's inserted.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through heart monitoring of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through heart monitoring of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through heart monitoring of 12 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

Temporal association between dialysis induced cardiac injury and electrophysiological substrate responsible for arrhythmia.

Temporal association between dialysis induced cardiac injury and frequency of arrhythmia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reveal LINQ insertable cardiac monitoring systemExperimental Treatment1 Intervention

In this all study, participants will have the option to undergo an insertion procedure of the Reveal LINQ insertable cardiac monitoring system on a dialysis or non-dialysis treatment day at University Hospital. The implantable loop recorder will be monitored at least once a week for up to 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reveal LINQ insertable cardiac monitoring system

2016

N/A

~100

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