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| Name | Class |
|---|---|
| AliveCor | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Monitoring | No Intervention | Standard of Care | |
| Kardia Monitoring | Experimental | Kardia Mobile/Kardia Pro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Atrial Fibrillation Detection | This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Atrial Fibrillation After Successful AF Ablation | Number (%) participants with Afib detected after ablation and during the study period. | 6 months |
| Number of Atrial Fibrillation Episodes Detected |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun G Tarajki, MD MPH | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Monitoring | Standard of Care: Patients will be followed clinically based on symptoms. |
| FG001 | Kardia Monitoring | Kardia Mobile/Kardia Pro 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized patients that did not withdraw consent early
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Monitoring | Standard of Care This is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Atrial Fibrillation Detection | This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm. | Randomized Patients that did not withdraw consent immediately | Posted | Mean | Standard Deviation | days | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care Monitoring | Standard of Care This is our current standard of care for following patients after successful AF ablation. Patients will be followed clinically based on symptoms (no monitor is provided). They will be seen for follow up 6 months after enrollment into the study. During these 6 months, patients can call if they have symptoms. The caring team will order any additional testing or monitors as deemed necessary by the patient's primary electrophysiologist. At the 6 months follow up visit with the patient's primary electrophysiologist, a 12 lead ECG is performed. The GAD7 will be administered at this visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Khaldoun Tarakji, MD, MPH | Cleveland Clinic | 216-445-9225 | TARAKJK@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2018 | Apr 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
Number of abnormal reading using Kardia Mobile after ablation
| 6 months |
| Average Number of Clinical Encounters After Successful Ablation | Average number of phone encounters within 6 months after successful ablation | 6 months |
| Number of Participants Using Alternative Monitoring Devices After Successful Ablation | Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval | 6 months |
| Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period | 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. | 6 months |
| BG001 | Kardia Monitoring | Kardia Mobile/Kardia Pro 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Afib at baseline | Count of Participants | Participants |
|
| CHADS-VASC score | CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score is a validated tool to predict the risk of stroke and systemic emboli in patients with non-valvular atrial fibrillation. Score ranges 0 - 6. Oral anticoagulation is recommended for those patients with a score of 2 or greater, and oral anticoagulant or aspirin may be considered for a CHA2DS2-VASc score of 1. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Kardia Monitoring | Kardia Mobile/Kardia Pro 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. |
|
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| Secondary | Incidence of Atrial Fibrillation After Successful AF Ablation | Number (%) participants with Afib detected after ablation and during the study period. | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Number of Atrial Fibrillation Episodes Detected | Number of abnormal reading using Kardia Mobile after ablation | Applies only to Kardia Mobile arm | Posted | Median | Inter-Quartile Range | Number of abnormal reading | 6 months |
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|
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| Secondary | Average Number of Clinical Encounters After Successful Ablation | Average number of phone encounters within 6 months after successful ablation | All randomized patients that did not withdraw consent immediately | Posted | Mean | Standard Deviation | Number of phone encounters | 6 months |
|
|
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| Secondary | Number of Participants Using Alternative Monitoring Devices After Successful Ablation | Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Kardia Monitoring | Kardia Mobile/Kardia Pro 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |