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OpenTrials
Completed

NCT Number: NCT03557034

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kardia Monitoring

Device

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.

Primary outcomes

  1. Time to Atrial Fibrillation Detection

    Time frame: 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 outcomes

  1. Incidence of Atrial Fibrillation After Successful AF Ablation

    Time frame: 6 months

    Number (%) participants with Afib detected after ablation and during the study period.

  2. Number of Atrial Fibrillation Episodes Detected

    Time frame: 6 months

    Number of abnormal reading using Kardia Mobile after ablation

  3. Average Number of Clinical Encounters After Successful Ablation

    Time frame: 6 months

    Average number of phone encounters within 6 months after successful ablation

  4. Number of Participants Using Alternative Monitoring Devices After Successful Ablation

    Time frame: 6 months

    Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval

  5. Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • AliveCor

Registry information

Acronym: AliveCor

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2018
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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