Clinical Research On-Label


A smart phone-based ECG recorder is non-inferior to an ambulatory event monitor for diagnosis of palpitations.

This oral presentation reported results from an ongoing trial evaluating the diagnostic yield of Kardia Mobile versus a 14-30 day event monitor, with the use of both devices simultaneously. All recordings were interpreted by cardiologists. All Kardia Mobile recordings were triggered by patients at symptom onset, while 44.5% of event monitor recordings were symptom-triggered. Among 23 patients with palpitations, the diagnostic yield for Kardia Mobile was non-inferior to an event monitor for overall rhythm disturbances, ectopy, and AF (33.3% vs. 23.8%, p<0.01, for AF). The authors concluded that Kardia Mobile can be used as a first approach for the diagnosis of palpitations.

Narasimha D, Hanna N, Beck H, Chaskes M, Glover R, Gatewood R, et al. Heart Rhythm Society’s Annual Scientific Sessions (2016). Presentation.

The effectiveness of a mobile ECG device in identifying AF: sensitivity, specificity, and predictive value.

Ninety-five patients, 29 with AF and 66 in sinus rhythm, were assessed with Kardia Mobile and a standard 12-lead EKG by two physicians in clinic. For one practitioner’s review, the sensitivity of Kardia Mobile was 90% and the specificity was 86%; for the other practitioner, the sensitivity was 93% and the specificity was 76%. The high sensitivity of Kardia Mobile suggests this test is a good ‘rule-out’ for AF. A positive test should be combined with a 12-lead EKG to confirm the diagnosis of AF.

Williams, J, Pearce K, Benett I. Br J Cardiol. 2015; 22:70-2.

iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke.

Kardia Mobile was used in a community screening of 109 patients (70 in sinus rhythm and 39 in AF) soon after a 12-lead ECG had been performed. The ECGs were interpreted by two cardiologists blinded to the rhythm diagnosis, and were processed to provide an automated diagnosis of sinus rhythm or AF. Results were compared with the 12-lead ECG diagnosis by a third cardiologist. An optimized algorithm performed extremely well in the validation set with high sensitivity, specificity, overall accuracy and Kappa (95% CI) of 98% (89%–100%), 97% (93%–99%), 97% (94%–99%) and 0.92 (0.86– 0.98) respectively. This study concluded that Kardia Mobile can be used to simply and rapidly record a high quality single-lead ECG to accurately detect AF, making it an ideal technology for community screening programs to detect silent AF.

Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, et al. Int J Cardiol. 2013;165(1):193-4.

Atrial fibrillation self-monitoring: patients versus algorithms.

The feasibility of twice-daily self-monitoring with Kardia Mobile was evaluated in 18 patients with paroxysmal AF and rhythm control management. Patients were instructed to recognize and notate sinus or AF. Over 3 months, the mean sensitivity of patient detection was 85% and the specificity was 98%; the Kardia Mobile AF algorithm sensitivity was 100% and specificity was 97%. Adherence to the twice-daily monitoring program declined over time, from median 83% to 58%.

Ross HM, Smith AJ. Heart Rhythm Society’s Annual Scientific Sessions (2016). PO06-40.


Screening for atrial fibrillation in 13,122 Hong Kong citizens with smartphone electrocardiogram.

From May 1, 2014, to April 30, 2015, adults aged 18 and above were informed by media promotion for a community-wide AF screening program in Hong Kong. A group of non-medical volunteers used Kardia Mobile to screen 13,122 Hong Kong citizens (mean age 65.5 ± 13.3 years). All recordings were overread by a cardiologist within 1 month of the recording, and all participants with AF detected were referred for medical consultation. Fifty-six (0.4%) out of 13,122 Kardia Mobile recordings were uninterpretable. Newly diagnosed AF was discovered in 101 (0.8%) participants. The overall prevalence for AF was 1.8% (23913,122, 95% CI 1.6-2%). Systematic population-based ECG screening for AF with Kardia Mobile was feasible and identified a proportion of Hong Kong citizens with AF that was comparable with that of contemporary US and European populations.

Chan NY, Choy CC. Heart. Published Online First: 12 Oct 2016. doi:10.1136/heartjnl-2016-309993.

Diagnostic performance of a smartphone-based photoplethysmographic application for atrial fibrillation screening in a primary care setting.

Kardia Mobile was used as a reference standard to analyze the diagnostic performance of a smartphone camera–based photoplethysmographic (PPG) pulse waveform measurement. 1,013 participants with hypertension, diabetes, and/or aged ≥65 years were recruited. Atrial fibrillation (AF) was diagnosed in 28 (2.76%). The diagnostic sensitivity of the Kardia Mobile automated algorithm for detecting AF was 71.4% [95% CI 51–87%], and the specificity was 99.4% [95% CI 99–100%]). The positive predictive value of the PPG application was lower than that of the Kardia Mobile automated algorithm (53.1% [95% CI 38–67%] versus 76.9% [95% CI 56–91%]); both had a very high negative predictive value (99.8% [95% CI 99–100%] versus 99.2% [95% CI 98–100%]).

Chan PH, Wong CK, Poh YC, Pun L, Leung WW, Wong YF, et al. J Am Heart Assoc. 2016;5(7).

Performance of handheld electrocardiogram devices to detect atrial fibrillation in a cardiology and geriatric ward setting.

The sensitivity and specificity of the automated algorithm for Kardia Mobile was assessed using 445 hospitalized patients, and the costs of identifying a new AF patient and preventing a stroke were estimated. On the cardiology ward, the sensitivity was 54.5% and the specificity was 97.5%. On the geriatrics ward, the sensitivity was 78.9% and the specificity was 97.9%. The accuracy of a peer-device, MyDiagnostick, was similar. In patients without an AF history, the Kardia Mobile algorithm was the most cost-effective method (€193 on the cardiology ward, €82 on the geriatric ward) to identify one new AF patient. Manual interpretation of Kardia Mobile recordings increased sensitivity but decreased specificity and doubled the cost per detected patient. AF screening using Kardia Mobile can be effective and cost-effective in a hospital setting if screening is targeted and structured.

Desteghe L, Raymaekers Z, Vijgen J, Dilling-Boer D, Koopman P, Schurmans J, et al. Europace. Published Online First: 17 February 2016. doi:10.1093/europace/ euw025.

Screening for atrial fibrillation during influenza vaccinations by primary care nurses using a smartphone electrocardiograph (iECG): a feasibility study.

Kardia Mobile was used to identify asymptomatic AF at the time of influenza vaccination in 5 practices in Sydney, Australia. Nurses used the automated algorithm to screen 973 patients aged ≥ 65 years between April-June 2015. Screening took on average 5 minutes (range 1.5 -10 minutes); abnormal recordings required additional time. Newly identified AF was found in 0.8% (8) of patients, and the overall prevalence of AF was 3.8% (37). The sensitivity and specificity of the automated algorithm for detecting AF was 95% and 99%, respectively. Screening by practice nurses was well accepted by practice staff. Key enablers were the confidence and competence of nurses and a ‘designated champion’ to lead screening at the practice. Barriers were practice specific, and mainly related to staff time and funding.

Orchard J, Lowres N, Freedman SB, Ladak L, Lee W, Zwar N et al. Eur J Prev Cardiol. 2016; 23(2S): 13-20.

The efficacy of a smartphone ECG application for cardiac screening in an unselected island population

Kardia Mobile was used to screen 954 participants aged 12-99. There were 54 (5.6%) people noted to have a potential abnormality (conduction defect, increased voltage, rhythm abnormality); of these 23 (43%) were abnormal with two confirming AF and 2 showing atrial utter. Other abnormalities detected included atrial and ventricular ectopy, bundle branch block, and left ventricular hypertrophy. One patient with increased voltages was later diagnosed with hypertrophic cardiomyopathy. In conclusion, Kardia Mobile was quick and easy to use and led to new diagnoses of arrhythmia, bundle branch block, left ventricular hypertrophy and cardiomyopathy.

Le Page P, McLachlan H, Anderson L, Penn L, Moss A, Mitchell A. Br J Cardiol. 2015; 22:31-3.

Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study.

One thousand pharmacy customers (mean age 76 ± 7 years, 44% male) were screened with Kardia Mobile. Newly identified AF was found in 1.5% (95% CI, 0.8-2.5%), and AF prevalence was 6.7%. The automated algorithm showed 98.5% sensitivity and 91.4% specificity for detecting AF. Using cost and outcome data from a United Kingdom study for AF screening, the incremental cost-effectiveness ratio of extending screening into the community with Kardia Mobile, based on 55% warfarin prescription adherence, would be $USD4,066 per quality-adjusted life-year gained, and $USD20,695 for preventing one stroke. In summary, screening for AF with Kardia Mobile is feasible and cost-effective.

Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, et al. Thromb Haemost. 2014;111(6):1167-76.

iPhone ECG screening by practice nurses and receptionists for atrial fibrillation in general practice: the GP-SEARCH qualitative pilot study

Receptionists and practice nurses screened patients aged ≥65 years using Kardia Mobile. General practitioner (GP) review was then provided during the patient’s consultation. Eighty-eight patients (51% male; mean age 74.8 ± 8.8 years) were screened: 17 patients (19%) were in AF (all previously diagnosed). Kardia Mobile was well accepted by GPs, nurses and patients. Receptionists were reluctant, whereas nurses were confident in using the device to explain and provide screening.

Orchard J, Freedman SB, Lowres N, Peiris D, Neubeck L. Aust Fam Physician. 2014;43(5):315-9.

Pharmacy-based screening for atrial fibrillation in high-risk Maori and Pacific populations

One hundred twenty-one Maori and Pacific people age ≥ 55 years were screened for AF with Kardia Mobile in New Zealand community pharmacies; if the automatic algorithm was positive, participants were referred to primary care for confirmatory 12-lead ECG. Two of the 121 participants screened had a new diagnosis of AF (1.7%), and two known AF cases appeared to not be receiving warfarin, giving a total of four people (3%) that could benefit from initiation of anticoagulation. There were 2 false positives, which were thought to occur due to incorrect handling of the device, which was corrected through further training of the pharmacists. The study determined that Kardia Mobile is highly acceptable to patient populations as well as health professionals in this environment.

Walker N, Doughty R, Parag V, Harrison J, Bennett M, Freedman B. N Z Med J. 2014;127(1398):128-31.

Medical outpatient clinics is an ideal setting for atrial fibrillation screening using a handheld single-lead ECG with automated diagnosis.

This study evaluated the feasibility of Kardia Mobile to screen for undiagnosed AF in 9,046 consecutive patients ≥ 65 years attending medical clinics between Dec 2014 to Jan 2016. All ECGs were over-read by a cardiologist. Approximately 10% of patients underwent repeated screening. Newly identified AF was found in 1.5% on a single screen, and an additional 1.2% was detected in those screened on multiple occasions. About 21% of newly diagnosed patients had a history of stroke, and 10% were taking oral anticoagulation for reasons other than AF. Overall AF prevalence was 9.4% (8509,046). Single-time point screening with Kardia Mobile is feasible and identified a significant number of patients at high risk of stroke. Repeated screening increased diagnostic yield.

Yan BP, Chan LL, Lee VW, Freedman B. European Society of Cardiology 2016 Congress. P4479.


A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol.

The iHEART study is a single center, prospective, randomized controlled trial. A total of 300 participants with a recent history of atrial fibrillation will be enrolled. Participants will be randomized 1:1 to receive the iHEART intervention, receiving an iPhone® equipped with a Kardia Mobile and behavioral altering motivational text messages or usual cardiac care for 6 months. This will be the first study to investigate the utility of a mobile health intervention in a “real world” setting. This study will assess the impact of Kardia Mobile on clinical outcomes, quality of life, quality-adjusted life-years and disease-specific knowledge.

Hickey KT, Hauser NR, Valente LE, Riga TC, Frulla AP, Masterson Creber R, et al. BMC Cardiovasc Disord. 2016;16:152.

Self-monitoring for atrial fibrillation recurrence in the discharge period post-cardiac surgery using an iPhone electrocardiogram.

This study aimed to determine the feasibility of patients self-monitoring with Kardia Mobile to identify recurrence of post-operative AF (POAF) in the post-discharge period following cardiac surgery. Forty-two participants with no prior history of AF, and discharged home in stable sinus rhythm, used Kardia Mobile 4 times per day for 4 weeks post-discharge. Self-monitoring for POAF recurrence using Kardia Mobile was feasible and acceptable, and participants felt empowered. Self-monitoring identified 24% (95% CI 12–39%) with an AF recurrence within 17 days of hospital discharge. 80% of patients with recurrence were at high enough stroke risk to warrant consideration of anticoagulation. The study concluded that Kardia Mobile is a non-invasive, inexpensive, convenient and feasible way to monitor for AF recurrence in post-cardiac surgery patients. It also provides a mechanism to provide knowledge about the condition and also potentially reduces anxiety.

Lowres N, Mulcahy G, Gallagher R, Freedman B, Marshman D, Kirkness A, et al. Eur J Cardiothorac Surg. 2016;50(1):44-51.

Using a novel wireless system for monitoring patients after the atrial fibrillation ablation procedure: the iTransmit study.

Fifty-five patients (mean age 60 ± 12 years) with AF undergoing ablation recorded their rhythm using Kardia Mobile and a traditional transtelephonic monitor (TTM) whenever they had symptoms, or at least once a week, for 3-4 months following ablation. All were interpreted by electrophysiologists. There were 831 Kardia Mobile recordings, and 7 were noninterpretable. Of the 389 simultaneous recordings with Kardia Mobile and TTM, there was excellent agreement (K statistic 0.82). Kardia Mobile detected sinus rhythm 97% of the time and correctly detected AF and atrial flutter 100% of the time, with 3% false-positive results. For manual review of Kardia Mobile versus TTM for detection of AF, Kardia Mobile had 97% specificity and 100% sensitivity. P waves could be difficult to discern, and occasionally this resulted in mislabeling sinus rhythm with atrial ectopy as AF. Kardia Mobile is an alternative method for monitoring patients after AF ablation, with patients agreeing on ease of use.

Tarakji KG, Wazni OM, Callahan T, Kanj M, Hakim AH, Wolski K, et al. Heart Rhythm. 2015; 12(3):554-9.

Detection of recurrent atrial fibrillation using novel technology.

This is a case study of a 58-year-old patient with AF with multiple cardiac risk factors who failed to remain in normal sinus rhythm after two ablations and one cardioversion. Following a second cardioversion, the patient was given Kardia Mobile for mobile monitoring of any symptomatic events. Within days, the patient began feeling symptomatic again and used his device to transmit an ECG to his healthcare provider. The novel technology led to more timely detection of recurrent AF. Since approximately one-third of patients with AF are asymptomatic, a daily ECG transmission in those who have undergone a prior cardioversion or AF ablation may prove useful in detecting silent AF.

Hickey KT, Dizon J, Frulla A. JAFIB. 2013; 6(4):50-1.