Clinical trials

Traditional Holter vs Peerbridge CorTM

In a clinical trial at Lenox Hill Hospital in New York City, Peerbridge technology delivered superior, multi-channel analyzable data, less motion artefact and fewer false positives than existing Holter technology.

Clinical Trial at Lenox Hill Hospital

In 2015, Peerbridge and Northwell Health, the owners of Lenox Hill Hospital, conducted a clinical trial that evaluated the Peerbridge Cor prototype alongside the traditional gold standard Holter monitoring technology.

Patients volunteered to be enrolled in the IRB-supervised, independent trial and wore the Peerbridge ECG side-by-side with a traditional Holter, while going about typical daily activities.

The objective of the trial was establishing the feasibility of the Peerbridge Cor capturing multi-channel diagnostic grade ECG in patients with Atrial Fibrillation (AF) and other arrhythmias.

Outputs

In a blinded review, three certified ECG technicians reviewed the ECG strips from both the Peerbridge product and the traditional Holter monitor:

  • 1,400 datasets were collected from each device (2,800 in total)
  • Data was processed using FDA-cleared arrhythmia algorithm
  • Datasets were randomly selected but time-matched between the devices to make sure like-for-like data was being compared
  • The data was scored on clarity and interpretability

Even though the technicians were unaware of which data came from which device, all three technicians reported significantly less artefact and fewer false positives from the Peerbridge Cor over the Holter monitor.

Nicholas Skipitaris, MD, chief of electrophysiology at Lenox Hill Hospital commented:

“The trial demonstrated Peerbridge technology was superior to the current Holter Monitor standard. Not only did the Peerbridge Cor deliver excellent, multi-channel, analyzable data, but it delivered less motion artifact and fewer false positives, despite our patient’s active New York lifestyle.”

Third-party clinical research findings informed the product development of Peerbridge Cor

Superior Data with three leads

A clinical study comparing 24-hour Holter monitoring and 14-day adhesive patch electrocardiographic monitoring (The American Journal of Medicine, Volume 127, No 1, January 2014), provided evidence of the superior data generated by multiple lead heart monitors compared to single lead devices:

“In general, the information provided by the Holter monitor’s additional 2 ECG leads are an obvious advantage for both automatic algorithm analysis and physician interpretation.

Specifically, 3-lead recordings allow for the detection of arrhythmia events characterized by a shift in electrical axis that can be missed by single-lead recordings.”

In the study, the Holter monitor with multiple leads detected 61 arrhythmia events compared with 52 arrhythmia events detected by the adhesive patch monitor which was single lead.

Seven days of monitoring delivers 96% detection of arrythmia

In the same study, a comparison between 24-hour Holter monitoring and 14-day adhesive patch electrocardiographic monitoring (The American Journal of Medicine, Volume 127, No 1, January 2014), sponsored by IRhythm, evidence showed seven days of continuous monitoring detects over 96% of arrythmias:

“Although short of the approved 14-day wear time, the median adhesive patch monitor wear time of 11.1 days in this study is likely a sufficient diagnostic window to capture arrhythmia events, because the highest diagnostic yield for arrhythmia detection is usually within the first 7 days of ambulatory ECG monitoring.

Ambulatory ECG monitoring beyond 7 days often provides only an additional 3.9% of patients with a diagnosis.”

Highly precise ECG measurements including the QT/QTc complex

Provides multi-channel information for diagnosis: 2 ECG channels, 3 leads, derived 6 channel option

Accessible real-time continuous event reporting for up to 7 days