Cardiac Monitoring System for Arrhythmia in Hemodialysis Patients

Not currently recruiting at 1 trial location

Overseen By Lisa Hur

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Must not be taking: Anti-arrhythmic drugs

Disqualifiers: Pacemaker, Chronic arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people on dialysis for kidney failure by monitoring their heart rhythms with a small device implanted under the skin (Reveal LINQ insertable cardiac monitoring system). The focus is on understanding how dialysis affects heart rhythm and causes heart injuries, which are common in these patients. Researchers will use this information, along with heart scans, to find ways to predict and possibly prevent heart problems during dialysis. This trial suits those who have been on dialysis for at least three months and have very little kidney function left. Participants should not have a pacemaker or a history of chronic irregular heartbeats. As an unphased trial, it offers a unique opportunity to contribute to vital research that could improve heart health for dialysis patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-arrhythmic drugs, you cannot participate in the study.

What prior data suggests that this cardiac monitoring system is safe for hemodialysis patients?

Research has shown that the Reveal LINQ heart monitor is generally well-tolerated by patients. The FDA has approved this device to help monitor heart rhythms in individuals at risk for heart issues. It is a small implant that tracks heartbeats and records any unusual patterns.

According to Medtronic, the company that manufactures the device, it is safe, though some patients might experience minor discomfort or irritation at the implant site. Serious problems are rare. Many patients have successfully used the device to monitor heart health over time.

Overall, the Reveal LINQ monitor is considered safe for long-term use. For specific concerns, consulting a healthcare professional is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Reveal LINQ insertable cardiac monitoring system is unique because it offers continuous, long-term heart monitoring for arrhythmias in hemodialysis patients. Unlike traditional external monitors that require patients to be tethered to devices and can be cumbersome, Reveal LINQ is a small, implantable device that provides seamless and unobtrusive monitoring. Researchers are excited about this technology because it can detect irregular heart rhythms more accurately and promptly, potentially leading to better management of cardiovascular risks in these patients.

What evidence suggests that this cardiac monitoring system is effective for arrhythmia in hemodialysis patients?

Research shows that the Reveal LINQ heart monitor effectively tracks heart rhythms in patients. This small device, placed under the skin, monitors heart activity over time. In this trial, participants can choose to undergo the insertion procedure for the Reveal LINQ insertable cardiac monitoring system. Studies have found it detects and helps manage irregular heartbeats in people on dialysis. This is crucial because dialysis patients face a high risk of sudden heart issues. The device uses advanced technology to provide accurate information, aiding doctors in understanding and predicting potential heart problems during dialysis. This data can guide better treatment and potentially reduce heart-related risks. ^{3 5 6 7 8}

Who Is on the Research Team?

Christopher W McIntyre, MD

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able/willing to provide informed consent

I produce less than 250ml of urine daily.

I have been on hemodialysis for at least 3 months.

Exclusion Criteria

I have a long-term irregular heartbeat and/or take medication for it.

I have a pacemaker or an implantable cardioverter defibrillator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Study Visits

Participants undergo external multichannel ECG, CT scan, CT angiogram, 2D echo, non-invasive monitoring of circulatory stress, and blood work during their midweek dialysis treatment day.

1 month

2 visits (in-person)

Device Insertion and Monitoring

Participants may undergo insertion of the Reveal LINQ insertable cardiac monitoring system, which will be monitored at least once a month for up to 12 months.

12 months

Monthly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a follow-up call 12 months after device insertion. Participants can choose to have the device removed or continue monitoring.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Reveal LINQ insertable cardiac monitoring system

Trial Overview 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.

How Is the Trial Designed?

Group I: Reveal LINQ insertable cardiac monitoring system Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04036695

NCT04036695 | Arrhythmia in Hemodialysis Patients 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5635540/

Frequency of arrhythmia symptoms and acceptability of ... Miniaturization of implantable cardiac monitors offers a new paradigm for detection and management of arrhythmias in dialysis patients. The goal ...

3. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiac-rhythm/cardiac-monitoring/insertable-cardiac-monitors/reveal-linq-icm.html

Reveal LINQ™ Insertable Cardiac Monitor The Reveal LINQ™ ICM with AccuRhythm™ AI algorithms is for patients with infrequent symptoms requiring long-term cardiac monitoring.

4. withpower.com withpower.com/trial/cardiac-monitoring-system-for-arrhythmia-in-hemodialysis-patients-62c4d

Cardiac Monitoring System for Arrhythmia in Hemodialysis ... The study uses a simple implantable device that can monitor heart rhythms over time to gather information on the type of abnormal rhythms that occur in dialysis ...

5. jacc.org jacc.org/doi/10.1016/j.jacep.2017.09.005

Hemodialysis Patients: High Risk for Sudden Death, But ... End-stage renal disease (ESRD) patients on hemodialysis are at high risk for mortality, with age-adjusted survival of 42% at 5 years after ...

6. medtronic.com medtronic.com/en-us/l/isw/cardiac-monitors-indications-safety-warnings.html

Indications, Safety, & Warnings - Cardiac Monitors The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult ...

7. medtronic.com medtronic.com/uk-en/patients/treatments-therapies/heart-monitors/our-monitors/important-safety-information.html

Heart Monitors - Important Safety Information REVEAL LINQ INSERTABLE CARDIAC MONITOR · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias · patients who experience ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527110012038

Safety and reliability of the insertable Reveal XT recorder ... Up to now there is little evidence about the safety and reliability of insertable cardiac monitors (ICMs) in patients undergoing magnetic resonance imaging ...