A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Phase: NA
Conditions: Atrial Fibrillation
Sponsor: The Cleveland Clinic

v. 28 FEB 2018 
 
NCT: 03557034 
Title: AF Clinic of The Future 
Using KardiaPro Platform for chronic care of patients with AF after ablation procedure  
Principle Investigator:  Khaldoun G. Tarakji, MD MPH 
Sponsor: AliveCor  
 
Background: 
Pulmonary vein isolation (PVI) is a widely used strategy for the treatment of patients with 
symptomatic atrial fibrillation (AF).  After ablation, patients are usually discharged with 
transtelephonic monitor. Patients are encouraged to send their electrophysiologist 
transmissions of their heart rhythm at least once a week or anytime they have symptoms. After 
3-4 months of remote monitoring, patients come for their first visit after the ablation. At this 
visit, the electrophysiologist reviews the heart rhythm transmissions since the ablation and 
based on the findings, decisions are made regarding anticoagulation or antiarrhythmic drug 
therapy. If all transmissions show sinus rhythm and the patient is doing well, he or she is 
normally followed clinically based on symptoms without any rhythm monitors. Usually, these 
patients follow up in another 6 months with an ECG at the time of the visit with the caring 
electrophysiologist. During these 6 months, patients might experience palpitations or recurrent 
arrhythmias. These episodes usually trigger phone encounters with the provider and this can 
trigger additional testing. Sometimes it might lead to clinic or emergency room encounters.  
Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds 
using the patient’s smart phone. The device has a built-in algorithm that detects AF. KardiaPro 
is a secure platform that allows the physician to access the patient’s recording at any time. The 
platform can also be programmed to send a notification to the healthcare provider if AF is 
detected by the software. The goal of our study is to determine whether detection of AF with 
Kardia Mobile is different than the current standard approach and to assess the value of using 
Kardia Mobile and the KardiaPro platform in decreasing health care utilization and reducing 
patient anxiety following AF ablation.  
 
Study Center: Cleveland Clinic 
 
Study Objectives: 
1. Determine whether detection of AF differs between standard of care (routine clinic visit 
with ECG) and the Kardia Mobile device for patients after initial successful AF ablation. 

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2. Determine whether the number of clinical encounters decreases with the use of Kardia 
Mobile compared to standard monitoring. 
3. Evaluate the effect of using Kardia Mobile in reducing patient’s anxiety (Using GAD-7 
anxiety scale) 
 
Study Design: 
This single center study will enroll approximately 100 patients with AF after successful AF 
ablation.  A successful AF ablation is defined as no documented AF episodes by ECG or 
ambulatory transtelephonic monitor after the first three weeks (blanking period) following AF 
ablation.  Patients typically see their electrophysiologist 3-4 months after the ablation.  At the 
time of this visit, eligible patients who provide informed consent will be randomized in 1:1 
fashion (standard of care vs Kardia Mobile Device). Randomization will be stratified by the type 
of atrial fibrillation at initial presentation (paroxysmal or persistent). Each patient is expected to 
participate for approximately 6-8 months post randomization. Both groups will participate in a 
standardized assessment of anxiety (GAD7) at the time of enrollment and at the 6 month visit.   
The 2 groups into which patients will be randomized include: 
1) Group 1 (Control) Standard of Care (SOC) monitoring:  This is our current standard of 
care for following patients after successful AF ablation. Patients will be followed 
clinically based on symptoms (no monitor is provided). They will be seen for follow 
up 6 months after enrollment into the study. During these 6 months, patients can 
call if they have symptoms. The caring team will order any additional testing or 
monitors as deemed necessary by the patient’s primary electrophysiologist. At the 6 
months follow up visit with the patient’s primary electrophysiologist, a 12 lead ECG 
is performed.  The GAD7 will be administered at this visit. 
 
2) Group 2 (Treatment) Kardia Mobile device: Patients randomized to the Kardia 
mobile device will be enrolled in the Kardia platform. They will be educated about 
the use of the device and instructed to record at least once weekly or when they 
have symptoms. The recordings are not reviewed routinely. However, the 
automated software provides an initial interpretation of the rhythm. The software 
will be programmed to send a notification to an EP nurse practitioner if the 
algorithm detects AF. This will be shared with the primary electrophysiologist. If the 
patient calls with symptoms, the EP nurse practitioner or the caring 
electrophysiologist can access the recordings for review. At the 6 months follow up 
visit, a report of the Kardia recordings will be provided to the primary 
electrophysiologist along with a standard 12 lead ECG.  The GAD7 will be 
administered at this visit. 

v. 28 FEB 2018 
 
 
Number of subjects: 100 patients 
Target Population: Patients with atrial fibrillation (paroxysmal or persistent) presenting 3-4 
months after successful AF ablation procedure. (Successful AF ablation is defined as maintaining 
sinus rhythm after the first 3 weeks blanking period) 
 
Inclusion Criteria: 
1. 18-85 years old 
2. Have smartphone with data plan 
3. History of AF (paroxysmal or persistent) 
4. In sinus rhythm at the 3-4 month post-procedure visit and no evidence of AF during 
the interval starting after the 3 week blanking period and ending at the appointment 
time.  
5. On Anticoagulation if CHADS VASC score is  1 and will continue to be on 
anticoagulation or CHADS VASC of Zero 
6. Willing to follow up with their Cleveland Clinic electrophysiologist in 6 months  
 
Exclusion Criteria 
1. Patients without smartphone 
2. Unwilling to provide consent 
3. Unwilling to follow up in 6 months 
4. CHADS VASC  1 and anticoagulation will be stopped 
5. Presence of a cardiac implantable electronic device  
6. If the primary electrophysiologist decides the patient still needs monitoring through 
traditional monitors due to any reason 
 
Randomization: 
Patients will be randomized in a 1:1 treatment allocation ratio to either standard of care or 
monitoring using the Kardia Mobile device. Randomization will be stratified by the type of atrial 
fibrillation at initial presentation (paroxysmal or persistent). 
 
Primary Endpoint 

v. 28 FEB 2018 
 
The primary endpoint is time to atrial fibrillation detection during the study period. Time zero is 
defined as the time of randomization.  
 
 
Secondary Endpoints 
The following are considered secondary endpoints: 
1) Incidence of atrial fibrillation within 6 months after successful AF ablation. 
2) Average number of atrial fibrillation episodes detected after ablation procedure 
3) Average number of clinical encounters within 6 months after successful ablation. 
4) Use of alternative monitoring devices during the follow up interval (Holter, Ziopatch)  
5) Change in level of anxiety from baseline to 6 months as measured by the Generalized 
Anxiety Disorder 7-item (GAD-7) scale 
 
Data Analysis: 
This is a descriptive pilot study and will enroll 100 patients meeting the inclusion and exclusion 
criteria.  The expected duration of follow-up for each patient is approximately 6 months.  The 
general statistical methodology will provide descriptive summaries and statistics on the entire 
cohort.  Categorical variables will be summarized using frequencies and percentages.  
Continuous variables will be summarized as mean, standard deviation, median, interquartile 
range and minimum and maximum values.  Only non-missing values will be reported. Missing 
data will not be imputed. 
 
Data Collection and Storage: 
All data will be entered into RedCap on a secured Cleveland Clinic server. Only investigators, 
research coordinators and statisticians involved in the study will have access to the data. Data 
will be collected mainly from the electronic medical record system, the EP lab database. Kardia 
Pro is a secure website and privacy statement will be provided to patients upon enrollment 
 
 
 
 
 

v. 28 FEB 2018 
 
 
 
Study Design Schematic: