A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

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.
    

Intervention name(s): Kardia Monitoring
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pulmonary vein isolation; atrial fibrillation; remote monitoring; heart rhythm monitor