A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure

Not Applicable

Completed

Conditions: Atrial Fibrillation

Interventions: Device: Kardia Monitoring

Registration Number: NCT03557034

Lead Sponsor: The Cleveland Clinic

Brief Summary: Pulmonary vein isolation is a widely used strategy for the treatment of patients with symptomatic atrial fibrillation. After successful pulmonary vein isolation (no atrial fibrillation on transtelephonic rhythm recordings for 3 months following ablation), heart rhythm is not routinely monitored. The goal of this study is to determine whether the Kardia Mobile device detects AF at a different rate compared to our standard of care. The study also hopes to understand how this Kardia Mobile device and Kardia Pro platform affect health care utilization and patient anxiety.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

18-85 years old
Have smartphone with data plan
History of AF (paroxysmal or persistent)
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.
On Anticoagulation if CHADS VASC score is ≥ 1 and will continue to be on anticoagulation or CHADS VASC of Zero
Willing to follow up with their Cleveland Clinic electrophysiologist in 6 months

Exclusion Criteria

Patients without smartphone
Unwilling to provide consent
Unwilling to follow up in 6 months
CHADS VASC ≥ 1 and anticoagulation will be stopped
Presence of a cardiac implantable electronic device
If the primary electrophysiologist decides the patient still needs monitoring through traditional monitors due to any reason

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kardia Monitoring	Kardia Monitoring	Kardia Mobile/Kardia Pro

Primary Outcome Measures

Name	Time	Method
Time to Atrial Fibrillation Detection	6 months	This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm.

Secondary Outcome Measures

Name	Time	Method
Number of Atrial Fibrillation Episodes Detected	6 months	Number of abnormal reading using Kardia Mobile after ablation
Average Number of Clinical Encounters After Successful Ablation	6 months	Average number of phone encounters within 6 months after successful ablation
Incidence of Atrial Fibrillation After Successful AF Ablation	6 months	Number (%) participants with Afib detected after ablation and during the study period.
Number of Participants Using Alternative Monitoring Devices After Successful Ablation	6 months	Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval
Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period	6 months	The Generalized Anxiety Disorder-7 is a scale to measure the severity of anxiety. It consists of asking patients to respond to a simple questionnaire and each answer is assigned a point based on the frequency of a given symptom (0=Not at all, 1=Several days, 2= More than half the days, 3=Nearly everyday). Total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. A total score of 5-9 indicates mild anxiety, 10-14 moderate anxiety, and \>15 severe anxiety.