Atrial Fibrillation
Conditions
Keywords
pulmonary vein isolation, atrial fibrillation, remote monitoring, heart rhythm monitor
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.
Interventions
DEVICEKardia 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.
Sponsors
AliveCor
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Atrial Fibrillation Detection | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Atrial Fibrillation After Successful AF Ablation | 6 months | Number (%) participants with Afib detected after ablation and during the study period. |
| Number of Atrial Fibrillation Episodes Detected | 6 months | Number of abnormal reading using Kardia Mobile after ablation |
| Average Number of Clinical Encounters After Successful Ablation | 6 months | Average number of phone encounters within 6 months after successful ablation |
| Number of Participants Using Alternative Monitoring Devices After Successful Ablation | 6 months | Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval |
| Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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. | 51 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care Monitoring | Kardia Monitoring | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 11.8 | 63.8 years STANDARD_DEVIATION 8.5 | 64.0 years STANDARD_DEVIATION 10.2 |
| CHADS-VASC score | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 44 Participants | 51 Participants | 95 Participants |
| Region of Enrollment United States | 48 participants | 51 participants | 99 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 35 Participants | 35 Participants | 70 Participants |
| Type of Afib at baseline Paroxysmal | 23 Participants | 26 Participants | 49 Participants |
| Type of Afib at baseline Persistent | 17 Participants | 16 Participants | 33 Participants |
| Type of Afib at baseline Unknown | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 51 |
| other Total, other adverse events | 0 / 48 | 0 / 51 |
| serious Total, serious adverse events | 0 / 48 | 0 / 51 |
Outcome results
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.
Time frame: 6 months
Population: Randomized Patients that did not withdraw consent immediately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Monitoring | Time to Atrial Fibrillation Detection | 85.0 days | Standard Deviation 62.8 |
| Kardia Monitoring | Time to Atrial Fibrillation Detection | 77.6 days | Standard Deviation 61 |
Secondary
Average Number of Clinical Encounters After Successful Ablation
Average number of phone encounters within 6 months after successful ablation
Time frame: 6 months
Population: All randomized patients that did not withdraw consent immediately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Monitoring | Average Number of Clinical Encounters After Successful Ablation | 2.9 Number of phone encounters | Standard Deviation 6.2 |
| Kardia Monitoring | Average Number of Clinical Encounters After Successful Ablation | 1.96 Number of phone encounters | Standard Deviation 2.7 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Monitoring | Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period | -1.23 units on a scale |
| Kardia Monitoring | Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period | 0.0 units on a scale |
Secondary
Incidence of Atrial Fibrillation After Successful AF Ablation
Number (%) participants with Afib detected after ablation and during the study period.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Monitoring | Incidence of Atrial Fibrillation After Successful AF Ablation | 7 Participants |
| Kardia Monitoring | Incidence of Atrial Fibrillation After Successful AF Ablation | 11 Participants |
Secondary
Number of Atrial Fibrillation Episodes Detected
Number of abnormal reading using Kardia Mobile after ablation
Time frame: 6 months
Population: Applies only to Kardia Mobile arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Kardia Monitoring | Number of Atrial Fibrillation Episodes Detected | 11 Number of abnormal reading |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Monitoring | Number of Participants Using Alternative Monitoring Devices After Successful Ablation | 13 Participants |
| Kardia Monitoring | Number of Participants Using Alternative Monitoring Devices After Successful Ablation | 3 Participants |