HeartWatch for Arrhythmia
(CATCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the HeartWatch, a new device for monitoring heart rhythm disorders like atrial fibrillation and slow heartbeats. Current options are either short-term or require surgery, but the HeartWatch is worn on the upper arm and pairs with a smartphone app for easy tracking of symptoms over a longer period. It suits individuals needing a Holter monitor test who can wear the HeartWatch on their left arm and have a bicep circumference between 22 cm and 45 cm. Participants should not have a pacemaker or defibrillator. As an unphased trial, this study allows participants to contribute to innovative research that could lead to more accessible heart monitoring solutions.
Do I need to stop my current medications for the HeartWatch trial?
The trial information does not specify whether 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 the HeartWatch device is safe for monitoring arrhythmias?
Research has shown that smartwatches, such as the HeartWatch, effectively detect heart rhythm issues. Specifically, studies have found these consumer smartwatches accurately identify atrial fibrillation, an irregular heartbeat. The FDA has approved them for this use, confirming their safety.
Smartwatches are generally easy to wear and comfortable, much like a regular watch. Studies have not reported any major safety concerns regarding their use for heart monitoring. This indicates that the HeartWatch, as a similar device, is likely safe for users.12345Why are researchers excited about this trial?
Researchers are excited about HeartWatch for arrhythmia because it offers a novel way to monitor heart rhythms more continuously and conveniently compared to traditional methods like the Holter monitor. Unlike the standard Holter monitor, which typically records heart activity over a short period, HeartWatch allows for ongoing real-time monitoring, potentially leading to quicker identification of irregular heartbeats. This continuous engagement could improve the management of arrhythmia by catching episodes that might be missed with intermittent monitoring, giving doctors better data to tailor treatments.
What evidence suggests that the HeartWatch is effective for detecting heart rhythm disorders?
Research has shown that wearable devices like HeartWatch, which participants in this trial will use, can accurately detect heart rhythm issues. Studies have found that similar technology is about 93% accurate in identifying serious heart rhythm problems. In one study, smartwatches detected atrial fibrillation (a type of irregular heartbeat) with high accuracy—96% sensitivity and 94% specificity. Another study found that smartwatches detected more irregular heartbeats than traditional monitors. This suggests that HeartWatch could effectively spot various heart rhythm disorders, potentially more reliably than older monitoring methods.14678
Who Is on the Research Team?
Russell Quinn, MD
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
This trial is for adults over 22 years old who need heart rhythm monitoring and can follow the study plan. They should not have a pacemaker or defibrillator, and their left bicep must measure between 22 cm and 45 cm in circumference.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Monitoring
Participants wear both the Holter monitor and the HeartWatch to collect and compare ECG data
Follow-up
Participants are monitored for safety and effectiveness after device monitoring
Data Analysis and Software Validation
Collected ECG data is used for future software validation
What Are the Treatments Tested in This Trial?
Interventions
- HeartWatch
Trial Overview
The HeartWatch device is being tested against conventional methods like Event Recorders or Holter monitors. It's worn on the upper arm, tags symptoms, and works with a smartphone app to track heart arrhythmias over time.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects will wear either the Holter monitor and the HeartWatch.
Find a Clinic Near You
Who Is Running the Clinical Trial?
HelpWear Inc.
Lead Sponsor
Citations
Detection and Diagnostic Accuracy of Cardiac Arrhythmias ...
PPG technology has proved nearly 93% accurate in detecting life-threatening cardiac arrhythmias.
2.
acc.org
acc.org/latest-in-cardiology/articles/2024/05/29/16/56/smartwatches-and-atrial-fibrillationSmartwatches and Atrial Fibrillation: What Works and What ...
The findings of two meta-analyses included high specificity (94%) and sensitivity (96%) for AF detection with smartphones and noninferiority of ...
Large-Scale Assessment of a Smartwatch to Identify Atrial ...
Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. There were no reports. The ...
Should I get a smart watch if I have heart issues?
The study also found that smart watches can help detect AFib, even for patients who have no symptoms. One study testing the Apple Watch found ...
Apple Watch Captures More Pediatric Arrhythmia Events Than ...
Apple Watch can capture arrhythmia events potentially more effectively than traditional ambulatory patch rhythm monitors.
Apple Watch Captures More Pediatric Arrhythmia Events
Apple Watch can capture arrhythmia events potentially more effectively than traditional ambulatory patch rhythm monitors. 79% of Apple Watch ...
Diagnostic Accuracy of Smartwatches for the Detection ... - PMC
This study aims to systematically review and meta-analyze the diagnostic accuracy of smartwatches in the detection of cardiac arrhythmias.
8.
thekeyholeheartclinic.com
thekeyholeheartclinic.com/blog/is-your-smartwatch-heart-data-actually-useful-or-misleading/Guide on Smartwatch Heart Data
It's important to note that currently, consumer smartwatches are generally only clinically validated (and FDA-cleared) to detect AFib, not other arrhythmias. So ...
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