Clinical trial NCT03557034: A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Official title: A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: pulmonary vein isolation
atrial fibrillation
remote monitoring
heart rhythm monitor
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: AliveCor
First posted: 2018-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Atrial Fibrillation Detection
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Atrial Fibrillation After Successful AF Ablation
timeFrame: 6 months
measure: Number of Atrial Fibrillation Episodes Detected
timeFrame: 6 months
measure: Average Number of Clinical Encounters After Successful Ablation
timeFrame: 6 months
measure: Number of Participants Using Alternative Monitoring Devices After Successful Ablation
timeFrame: 6 months
measure: Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Khaldoun G Tarajki, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: