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



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:7/27/2018
Start Date:June 27, 2018
End Date:May 2020
Contact:Khaldoun G Tarajki, MD MPH
Email:Tarakjk@ccf.org
Phone:(216) 445-9225

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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.

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.

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
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-9225
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