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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Temporal association between dialysis induced cardiac injury and electrophysiological substrate responsible for arrhythmia.
Temporal association between dialysis induced cardiac injury and frequency of arrhythmia
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
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,410 Total Patients Enrolled
Christopher W McIntyre, MDPrincipal InvestigatorLondon Health Sciences Centre
4 Previous Clinical Trials
154 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term irregular heartbeat and/or take medication for it.I am 18 years old or older.I have a pacemaker or an implantable cardioverter defibrillator.I have been on hemodialysis for at least 3 months.I produce less than 250ml of urine daily.
Research Study Groups:
This trial has the following groups:- Group 1: Reveal LINQ insertable cardiac monitoring system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this clinical investigation?
"Affirmative. Clinicaltrials.gov's information suggests that this clinical trial, first posted on October 17th 2019, is open for enrollment at present time. Approximately 30 individuals need to be enrolled from 2 separate medical facilities."
Answered by AI
Are there any available slots to participate in this experiment?
"Affirmative, clinicaltrials.gov data suggests that this trial is continually seeking participants. It was initially posted on October 17th 2019 and amended most recently on March 29th 2021. The study requires 30 volunteers from two different clinics."
Answered by AI
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