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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kardia Monitoring
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring pulmonary vein isolation, atrial fibrillation, remote monitoring, heart rhythm monitor

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Monitoring

Kardia Monitoring

Arm Description

Standard of Care

Kardia Mobile/Kardia Pro

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of Atrial Fibrillation After Successful AF Ablation
Number (%) participants with Afib detected after ablation and during the study period.
Number of Atrial Fibrillation Episodes Detected
Number of abnormal reading using Kardia Mobile after ablation
Average Number of Clinical Encounters After Successful Ablation
Average number of phone encounters within 6 months after successful ablation
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
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.

Full Information

First Posted
June 4, 2018
Last Updated
July 14, 2021
Sponsor
The Cleveland Clinic
Collaborators
AliveCor
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1. Study Identification

Unique Protocol Identification Number
NCT03557034
Brief Title
A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Acronym
AliveCor
Official Title
A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
AliveCor

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
pulmonary vein isolation, atrial fibrillation, remote monitoring, heart rhythm monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Monitoring
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Kardia Monitoring
Arm Type
Experimental
Arm Description
Kardia Mobile/Kardia Pro
Intervention Type
Device
Intervention Name(s)
Kardia Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Atrial Fibrillation Detection
Description
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
Secondary Outcome Measure Information:
Title
Incidence of Atrial Fibrillation After Successful AF Ablation
Description
Number (%) participants with Afib detected after ablation and during the study period.
Time Frame
6 months
Title
Number of Atrial Fibrillation Episodes Detected
Description
Number of abnormal reading using Kardia Mobile after ablation
Time Frame
6 months
Title
Average Number of Clinical Encounters After Successful Ablation
Description
Average number of phone encounters within 6 months after successful ablation
Time Frame
6 months
Title
Number of Participants Using Alternative Monitoring Devices After Successful Ablation
Description
Additional ECGs and ambulatory heart rhythm monitoring used (Holter, Ziopatch) during the follow up interval
Time Frame
6 months
Title
Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-85 years old Have smartphone with data plan History of AF (paroxysmal or persistent) 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. On Anticoagulation if CHADS VASC score is ≥ 1 and will continue to be on anticoagulation or CHADS VASC of Zero Willing to follow up with their Cleveland Clinic electrophysiologist in 6 months Exclusion Criteria: Patients without smartphone Unwilling to provide consent Unwilling to follow up in 6 months CHADS VASC ≥ 1 and anticoagulation will be stopped Presence of a cardiac implantable electronic device If the primary electrophysiologist decides the patient still needs monitoring through traditional monitors due to any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaldoun G Tarajki, MD MPH
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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