Abstract

Aims

To show the technical feasibility of the S-Patch monitor and anlysis system and to demonstrate equivalency to usual Holter 24-hour ambulatory ECG. 

Methods

Open-label trial with simultaneous S-Patch and Holter monitoring for 24 hours. After an initial Beta-testing in 25 patients, 60 patients were studied (no changes to hardware/software). An experienced Cardia Physiologist analyzed and reported the S-Patch and Holter data separately. The reports were clinically interpreted separately by an Electrophysiologist. 

Results

Indications for monitoring were palpitations in 9, syncope in 7, presyncope in 4, HCM in 2, TIA in 1, PVC in 1, other symptoms in 1 patient.

The volume of data from the S-Patch is less and likely relates to Bluetooth dropout. The heartbeat parameters measured were similar. There was agreement on the clinical conclusion in every patient from the 2 monitoring modalities (Holter and S-Patch).

Conclusion 

The S-Patch monitor and analysis system provides clinically appropriate ambulatory ECG monitoring. It is a potential alternative to less convenient and more expensive traditional Holter testing.