iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Phase: NA
Conditions: Atrial Fibrillation, Atrial Flutter
Sponsor: Columbia University

iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) Study 
(NCT02731326)
Study Design 
The iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) study is 
a single-center, prospective, randomized controlled trial (RCT) (Figure 1). The primary aims of 
the iHEART study are to: (1) Examine the efficacy of mHealth ECG technology (iHEART 
intervention) on the detection and treatment of recurrent AF as compared to usual cardiac care 
(control group); (2) Evaluate the quality-adjusted life-years (QALYs) in those in the iHEART 
intervention as compared to the control group between baseline and 6 months; (3) Determine 
the impact of behavior altering, motivational text messages on chronic cardiovascular conditions 
(e.g., hypertension, diabetes) and AF knowledge over 6 months.  Participants are randomized 
to one of two groups: iHEART (intervention group) or usual care (control group). All participants 
enrolled will be followed for a period of 6 months. This study protocol adheres to the appropriate 
standards of reporting as stated in the Standard Protocol Items: Recommendations for 
Interventional Trials statement and facilitates the methodology of the Consolidated Standards of 
Reporting Trials statement for later dissemination of the results of the outlined RCT. 
Study Population 
Patients will be screened for eligibility (Table 1). Those who meet inclusion criteria will be 
approached for enrollment after the patient’s provider agrees to the study protocol and is willing 
to receive and review ECG transmissions. The details of the study will be explained in English 
or Spanish, and patients will be given an opportunity to ask questions before signing informed 
consent. A copy of the consent form will be given to the patient.  
Inclusion criteria will include documented AF that has been treated in the last 30 days resulting 
in the restoration of normal sinus rhythm. The operational definition of AF for this study will 
include the presence of AF captured by the AliveCor® Mobile ECG, a standard 12 lead ECG, 
Holter, or any other external recording mechanism that documents AF. Over a six-month period, 
those individuals with ≤ 7 days of AF will be considered paroxysmal, and those with greater than 
7 days of continuous AF will be defined as persistent AF per the AHA/ACC/HRS guidelines.   
The main exclusion criteria for participants include documented permanent (chronic) AF, 
unwillingness to use technology and have one’s clinical data collected over the study period, 
unwillingness to receive and read cardiovascular text messaging three times a week, and 
patients who have a documented medical history of cognitive impairment.  
Data and Safety Monitoring  
The study was approved by the Columbia University Medical Center Institutional Review Board. 
Participants provide written informed consent prior to enrollment and all data collection 
procedures are in accordance with the Health Information Portability and Accountability Act 
regulations.  
Sample Size 
A total of 300 participants with documented AF who are undergoing clinical treatment of their AF 
with electrical cardioversion, radiofrequency ablation and/or medical management to restore 
normal sinus rhythm will be enrolled. After a normal rhythm is restored, participants will be 
randomized to usual cardiac care (n= 150) or usual cardiac care plus the iHEART intervention 
(n= 150). The population will be recruited from the Columbia University Medical Center (CUMC) 
cardiac services and will include English and Spanish speaking participants. 
IRB approval: August 15, 2020

Randomization 
The randomization process will be performed by a random computer number generator in a 
one-to-one block allocation ratio. In order to achieve a balance of applicable participant 
characteristics in both the intervention and control groups, participants will be stratified based on 
age and gender.  
  
Outcome assessments 
Upon study entry, all relevant clinical data will be collected at baseline and monthly throughout 
six months via an electronic medical records system review. This will be used to capture and 
quantify cardiac outcomes in both groups. In addition, all outside medical records will be 
requested, and participants will be contacted monthly to capture any hospitalizations, cardiac 
events, or changes in therapy that may occur outside of our center and clinics. AF in the usual 
care group may be detected during routine follow-ups with providers, as well as during self-
evaluations such as a pulse check initiated as a result of participant-reported symptoms or 
changes in health status. AF may also be captured by a 12-lead ECG, pulse check, or heart 
sound auscultation during an exam that reveals an irregular heart rhythm. Participants in the 
usual care group may seek medical evaluation by their providers because of a change in their 
health status or symptoms (shortness of breath, palpitations, fatigue), which may lead to further 
cardiac monitoring or testing (e.g., echocardiogram) that may reveal AF. This could include 
Holter monitoring (24 hour) or extended cardiac monitoring (7-30 days) that may document AF 
and be the basis for changes in treatments prescribed by their providers (e.g., medication 
changes or dosage adjustments, cardioversion). In the intervention group, AliveCor® Mobile 
ECG transmissions will be read daily to detect recurrence of AF or other arrhythmias. All results 
and any treatment changes due to mobile ECG findings will be recorded over the course of the 
study period. 
 
All study participants will be asked to complete a series of questionnaires including the Atrial 
Fibrillation Knowledge Scale (AFKS), the Canadian Cardiovascular Society Severity in Atrial 
Fibrillation scale (CCS-SAF), the Atrial Fibrillation Effect on Quality of Life (AFEQT), the Control 
Attitudes Scale-Revised (CAS-R), the Morisky 4-item Self-Report Measure of Medication-Taking 
Behavior (MMAS-4), the Self-Efficacy for Appropriate Medication Use Scale (SEAMS), the Short 
Form Health Survey (SF-36 Quality of Life), European Questionnaire 5 Dimensions (EQ-5D), 
the Patient Health Questionnaire (PHQ-9), and the State Trait Anxiety Inventory (STAI). These 
measures will be administered to both the intervention and control groups at baseline prior to 
any procedures, such as a cardioversion or ablation, and again at the 6-month follow-up visit for 
the purpose of comparison.  
 
Study Intervention 
Participants randomized to the iHEART intervention will receive an iPhone® and cellular service 
plan with unlimited data/text messaging, the AliveCor® Mobile ECG, and Behavioral Altering 
Motivational (BAM) text messaging three times a week for six months. BAM is an in-house 
database that automatically sends one-way text messages to the intervention participant related 
to their AF, as well as two underlying cardiovascular risk factors of their choosing. 
   
AliveCor™ Heart Monitor 
The AliveCor® Mobile ECG, an FDA-approved smartphone technology, works through a free 
application, “Kardia.” It captures a highly sensitive (98%), specific (97%), and accurate (97%) 
single-lead ECG recording through two electrodes on the back of the smartphone[7]. When the 
application is opened, recording begins automatically when both electrodes make contact with 
skin (Figure 2). Transmissions are automatically uploaded to the study portal within the 

AliveCor® “cloud”. All participants will receive in-person training on the use of the study 
equipment at enrollment. A return demonstration from the participant to the research coordinator 
will be required at baseline enrollment. This will include how to capture an ECG daily and in the 
setting of symptoms, as well as how to record any associated symptoms in the application. 
 
All ECG images and any associated symptoms will be sent via WiFi or cellular network 
transmission to the AliveCor® cloud. A login will occur daily to the password-protected study 
database that will be stored on the AliveCor® cloud in order to review and interpret all ECG 
strips transmitted during the previous 24 hours.  Any clinically significant arrhythmias, including 
AF or other arrhythmias, detected during the daily review of ECGs over the 6-month period will 
be immediately sent to the provider caring for the participant. The study team will ensure the 
provider has received the transmission, is aware of any ECG abnormalities, and will then be 
responsible for communicating such findings.  
 
Smartphone 
The study is innovative in its use of mHealth and widely available smartphone technology, which 
allows rapid two-way communication between patients and healthcare providers, rather than 
waiting for office or clinic visits that delay care.  An FDA-approved smartphone technology is 
being used, the AliveCor® Mobile ECG to capture and send ECG data via WiFi or cellular 
network for immediate interpretation. Transmission of a normal ECG while a patient is 
experiencing a symptom with multiple underlying diagnoses impacts immediate triage and 
treatment of the symptom. The AliveCor® technology allows clinicians to correlate symptoms 
with heart rhythms.  
 
Unlike previous ECG technology, the AliveCor® Mobile ECG is not worn, so it eliminates the 
need for adhesive ECG electrodes and skin patches placed on the chest and does not require 
complicated changing of leads by the subject. This is a significant improvement from previously 
available technology. The use of tailored cardiac behavior altering motivational (BAM) text 
messaging sent to an individual’s smartphone to improve AF awareness and knowledge, as well 
as self-management of pre-existing chronic cardiovascular conditions associated with AF will be 
simultaneously evaluated. 
 
Behavior Altering Motivational (BAM) Text Messaging 
BAM one-way text messages are sent to the intervention participant three times per week and 
pertain to their AF, as well as two underlying cardiovascular risk factors of the patient’s choosing 
(weight management, physical activity, hypertension, heart failure, diabetes, etc.). Starting on 
the day of enrollment, intervention participants will receive text messages every Wednesday 
related to AF management, as well as a message on Monday related to risk factor one and a 
message on Friday related to risk factor two. BAM text messages will be systematically selected 
from a bank of text messages developed through collaboration by the study team and an expert 
interdisciplinary panel from the American Heart Association. All messages are available in 
English and Spanish according to participant preference. 
 
Control Group (Usual Care) 
Participants randomized to usual care will continue their guideline-directed clinical management 
and follow-up as determined by their providers’ interpretation of the 2014 ACC/AHA/HRS 
Guideline for the Management of Patients with Atrial Fibrillation.   
 
Study end-points 

The primary endpoint is detection of recurrence of AF. Secondary endpoints include treatment 
changes as a result of early detection of AF recurrence, study questionnaire scores at baseline 
and six months, including QoL, QALYs, and improvement in cardiovascular measures (e.g., 
blood pressure, glucose levels) and AF knowledge from baseline to 6 months. Outcome 
assessors will be blinded to group allocation. 
 
Statistical Analysis 
We will define and calculate recurrent AF detection rate as the ratio of the number of recurrent 
AF episodes to the number of person-months of follow-ups. We will compare the difference in 
recurrent AF detection rate over the six-month study period between the control group and the 
iHEART intervention group. Analysis of the potential moderating effects of demographic factors 
(e.g., age, gender, etc.) as well as the difference between the groups will be performed using 
multivariate Poisson regression. 
 
We will compare the time-to-treatment between the iHEART intervention group and the control 
group with the application of survival analysis methods. For those who are treated for recurrent 
AF, the time-to-treatment is the time from beginning of study to the time of treatment. Those 
who are not treated for recurrent AF will be censored at the end of the sixth month, or the time 
of death should a subject die before the sixth month. We will apply the Cox proportional hazard 
model to examine and test the difference in the time-to-treatment between the intervention 
group and control group, with the adjustment for other potential confounders (e.g., age, gender).  
QALYs are calculated as follows: for each month of life lived at an EQ-5D index of x, the QALYs 
will be x/12=0.0833x years. We will calculate QALYs during the 6-month study period for all 
participants by summarizing QALYs from baseline through sixth month. We will compare QALYs 
between the iHEART intervention group and the control group using a two-tailed independent 
sample t-test. To adjust for potential confounders (e.g., age, gender), multivariate linear 
regression models will be used. Additionally, we will compare change of quality of life (QoL) and 
symptoms of AF scores (AFEQT, AFKS, EQ5D and CCS-SAF scales, etc.) from baseline to 6 
months between the two groups and between those with and without AF using linear mixed 
models (growth model). 
 
 

Figure 1. Flowchart for Study Procedures 
 
 
 
 
Figure 1. Flowchart for Study Procedures 
 
 
 
 

Table 1.  Inclusion and Exclusion Criteria 
Inclusion Criteria 
• Males and females (English or Spanish 
speaking) age ≥ 18 years with a prior history 
of AF in the last 30 days that was treated 
and normal rhythm restored 
• Already utilizes a smartphone prior to 
enrollment 
• Ability to successfully use the AliveCor™ 
Heart Monitor, capture a baseline ECG, and 
transmit on the day of enrollment 
• Demonstrated ability to receive and read text 
messages on the day of enrollment 
• Willingness to complete the study 
questionnaires at baseline and 6 months 
Exclusion Criteria 
• Documented permanent (chronic) 
AF   
• Unwillingness to have their clinical 
data collected over the study 
period 
• Unwillingness to receive and read 
cardiovascular text messaging 
three times a week.