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

• ClinicalTrials.gov Identifier: NCT03557034
• Recruitment Status: Completed
• First Posted: June 14, 2018
• Results First Posted: July 15, 2021
• Last Update Posted: July 15, 2021
• Sponsor: The Cleveland Clinic
• Collaborator: AliveCor
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Kardia Monitoring	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
• Actual Study Start Date: June 27, 2018
• Actual Primary Completion Date: February 21, 2020
• Actual Study Completion Date: August 15, 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Standard of Care Monitoring; Standard of Care
Experimental: Kardia Monitoring; Kardia Mobile/Kardia Pro	Device: Kardia Monitoring; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

AliveCor

Investigators

• Principal Investigator: Khaldoun G Tarajki, MD MPH; The Cleveland Clinic

  Study Documents (Full-Text)

Documents provided by The Cleveland Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] February 28, 2018

More Information

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03557034
• Other Study ID Numbers: 18-444
• First Posted: June 14, 2018
• Results First Posted: July 15, 2021
• Last Update Posted: July 15, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by The Cleveland Clinic:

pulmonary vein isolation; atrial fibrillation; remote monitoring; heart rhythm monitor

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes