Cardiac Monitoring Device for Atrial Fibrillation Detection

(DETECT-POAF Trial)

Recruiting at 6 trial locations

Overseen By Kate Brady

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Chronic AF, Severe renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to detect atrial fibrillation, a type of irregular heartbeat, that might occur after non-heart surgery. Participants will wear a small device that continuously monitors heart activity for up to 14 days post-surgery. The goal is to identify any irregular heartbeats during recovery. Individuals who have recently undergone non-heart surgery and stayed overnight in the hospital may be suitable for this study.

As an unphased study, this trial offers a unique opportunity to contribute to important research that could enhance post-surgery care for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cardiac monitoring device is safe?

Research has shown that heart monitoring devices are generally safe for individuals at higher risk of heart rhythm problems. The FDA has approved these devices to track heart rate and rhythm, functioning like a continuous EKG that records the heart's activity.

Although they are usually well-tolerated, some side effects might occur, such as allergic reactions, bleeding, or other minor issues. However, these are rare. Overall, heart monitors are designed to be safe and aid in the early detection of heart issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for detecting perioperative atrial fibrillation, which often rely on intermittent monitoring methods like Holter monitors or patient-reported symptoms, this trial is exploring continuous cardiac monitoring for up to 14 days. This approach is unique because it can potentially identify atrial fibrillation episodes that might otherwise be missed with traditional monitoring. Researchers are excited about this method as it could lead to earlier detection and more timely interventions, ultimately improving patient outcomes after noncardiac surgeries.

What evidence suggests that this cardiac monitoring device is effective for post-surgery patients?

Research has shown that wearable heart monitors, like the cardiac monitoring device used in this trial, effectively detect atrial fibrillation, a common irregular heartbeat. One study found these devices correctly identified atrial fibrillation 94% of the time and correctly ruled it out 96% of the time. Another study demonstrated that using these monitors led to changes in medical treatment for up to 35% of users, thanks to real-time heart issue detection. Additionally, patients reported saving time and money by using these monitors. Overall, strong evidence supports that these devices effectively spot heart rhythm problems after non-heart-related surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

David Conen, MD, MPH

Principal Investigator

Population Health Research Institute

Michael K Wang, MD

Principal Investigator

Population Health Research Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I stayed in the hospital overnight after surgery.

I am having a major surgery that is not minor or under local anesthesia only.

I meet one of the high-risk criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants receive up to 14 days of continuous ECG monitoring starting within 72 hours after noncardiac surgery

2 weeks

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after monitoring period

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac monitoring device

How Is the Trial Designed?

Group I: Study Cohort Experimental Treatment 1 Intervention

Participants will receive up to 14 days of continuous cardiac monitoring

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10522456/

Patient Outcomes Associated with the First Remote ... The study participants were satisfied with their first remote monitoring experience and reported having time- and cost-savings by using remote monitoring.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002870323003459

Comparative effectiveness and healthcare utilization for ... The Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (CAMELOT) study is a retrospective cohort study using the full (100%) Medicare Fee-For- ...

3. becarispublishing.com becarispublishing.com/doi/10.57264/cer-2024-0008

Comparing the outcomes and costs of cardiac monitoring ... Results: In 2244 patients, readmissions were significantly lower in the MCOT monitored group (30.2%) compared with the ILR group (35.4%) (hazard ...

4. ccjm.org ccjm.org/content/91/1/23

Consumer-grade wearable cardiac monitors: What they do ... A recent meta-analysis found that smartphones detected atrial fibrillation with a sensitivity of 94% and a specificity of 96%, and there was no ...

5. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/the-efficacy-of-wearable-cardiovascular-monitoring-devices-in-real-time-arrhythmia-detection-systematic-review-3415/

The Efficacy of Wearable Cardiovascular Monitoring ... Results: Wearables demonstrated sensitivity ranging from 84% to 95% and specificity up to 93%. Intervention changes occurred in up to 35% of ...

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

Indications, Safety, & Warnings - Cardiac Monitors Cardiac monitors are indicated for patients with increased risk of arrhythmias or transient symptoms like dizziness, palpitation, syncope, and chest pain.

7. cardiovascular.abbott cardiovascular.abbott/us/en/patients/treatments-therapies/cardiac-monitors/important-safety-information.html

Patient Cardiac Monitoring Important Safety Information Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, ...

8. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/cardiac-monitors/lux-dx--insertable-cardiac-monitor-icm-system-/fp00000496/lux-dx-indications-safety-warnings.html

Indications, safety, and warnings The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm.

9. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/23272-cardiac-event-monitor

Cardiac Event Monitor (Heart Monitor) A heart monitor is a small device that records your heart rate and rhythm, like an EKG, to help diagnose heart issues, especially for non-daily symptoms.

10. fda.gov fda.gov/regulatory-information/search-fda-guidance-documents/cardiac-monitor-guidance-including-cardiotachometer-and-rate-alarm-guidance-industry

Cardiac Monitor Guidance (including Cardiotachometer ... This FDA guidance aids in premarket notification for cardiac monitors, including cardiotachometers and rate alarms, and covers devices under the ANSI/AAMI EC13 ...