NewCardio has reported positive results from a clinical study evaluating CardioBip, a hand-held device which provides a solution for ECG telemonitoring.
The CardioBip can be carried by the patients and it records and wirelessly transmits information sufficient to reconstruct a full 12-lead ECG, which enables the physician to detect atrial fibrillation (AF) recurrences.
The study results showed that in patients who used CardioBip for daily monitoring following catheter ablation procedures, recurrent AF was accurately detected.
In the study, 21 patients who underwent catheter ablation for AF were given CardioBip devices and asked to provide daily transmissions for 60 days.
Patients also underwent 24-hour, continuous 12-lead ECG recordings (Holter monitors [HM]), a commonly-used method for AF surveillance, at 30 and 60 days post-procedure.
The study results showed that 20 of 21 patients had at least one episode of recurrent AF detected by CardioBip and six of the 20 patients also had occurrence of atrial flutter (AFLT) detected.
However, only four and two patients had recurrent AF and AFLT detected by 12-lead HM, respectively.
NewCardio chief technical officer Dorin Panescu said the study data show that CardioBip has the potential to contribute to clinical management of patients affected by atrial fibrillation.