Trial Outcomes & Findings for A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure (NCT NCT03557034)

NCT ID: NCT03557034

Last Updated: 2021-07-15

Results Overview

This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-07-15

Participant Flow

Participant milestones

Measure	Standard of Care Monitoring Standard of Care: Patients will be followed clinically based on symptoms.	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.
Overall Study STARTED	49	51
Overall Study Randomization	49	51
Overall Study COMPLETED	48	51
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Standard of Care Monitoring Standard of Care: Patients will be followed clinically based on symptoms.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care Monitoring n=48 Participants 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.	Kardia Monitoring n=51 Participants 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.	Total n=99 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	63.8 years STANDARD_DEVIATION 8.5 • n=7 Participants	64.0 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	51 Participants n=7 Participants	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	51 participants n=7 Participants	99 participants n=5 Participants
Type of Afib at baseline Paroxysmal	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Type of Afib at baseline Persistent	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Type of Afib at baseline Unknown	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
CHADS-VASC score	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Randomized Patients that did not withdraw consent immediately

This outcome will measure the time between the ablation procedure (time zero) and the time of first detected atrial fibrillation heart rhythm.

Outcome measures

Measure	Standard of Care Monitoring n=48 Participants 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.	Kardia Monitoring n=51 Participants 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.
Time to Atrial Fibrillation Detection	85.0 days Standard Deviation 62.8	77.6 days Standard Deviation 61.0

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Standard of Care Monitoring n=48 Participants 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.	Kardia Monitoring n=51 Participants 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.
Incidence of Atrial Fibrillation After Successful AF Ablation	7 Participants	11 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Applies only to Kardia Mobile arm

Number of abnormal reading using Kardia Mobile after ablation

Outcome measures

Measure	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.	Kardia Monitoring n=51 Participants 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.
Number of Atrial Fibrillation Episodes Detected	—	11 Number of abnormal reading Interval 2.0 to 16.0

SECONDARY outcome

Timeframe: 6 months

Population: All randomized patients that did not withdraw consent immediately

Average number of phone encounters within 6 months after successful ablation

Outcome measures

Measure	Standard of Care Monitoring n=48 Participants 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.	Kardia Monitoring n=51 Participants 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.
Average Number of Clinical Encounters After Successful Ablation	2.9 Number of phone encounters Standard Deviation 6.2	1.96 Number of phone encounters Standard Deviation 2.7

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Standard of Care Monitoring n=48 Participants 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.	Kardia Monitoring n=51 Participants 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.
Number of Participants Using Alternative Monitoring Devices After Successful Ablation	13 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard of Care Monitoring n=48 Participants 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.	Kardia Monitoring n=51 Participants 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.
Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period	-1.23 units on a scale Interval -2.6 to 0.17	0.0 units on a scale Interval -1.4 to 1.4

Adverse Events

Standard of Care Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Kardia Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Khaldoun Tarakji, MD, MPH

Cleveland Clinic

Phone: 216-445-9225

Email: TARAKJK@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place