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

NCT03557034 | Completed Results FDA Device

• 1 other identifier: 18-444
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Incidence of Atrial Fibrillation After Successful AF Ablation

  6 months

• Number of Atrial Fibrillation Episodes Detected

  6 months

• Average Number of Clinical Encounters After Successful Ablation

  6 months

• Number of Participants Using Alternative Monitoring Devices After Successful Ablation

  6 months

• Change in Level of Anxiety From the Date of Atrial Fibrillation Ablation to the End of Study Period

  6 months

Study Arms (2)

Standard of Care Monitoring

NO INTERVENTION

Standard of Care

Kardia Monitoring

EXPERIMENTAL

Kardia Mobile/Kardia Pro

Device: Kardia Monitoring

Interventions

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.

Kardia Monitoring

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• AliveCor: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Khaldoun Tarakji, MD, MPH
• Organization: Cleveland Clinic

TARAKJK@ccf.org

216-445-9225

Study Officials

• Khaldoun G Tarajki, MD MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: June 27, 2018
• Primary Completion: February 21, 2020
• Study Completion: August 15, 2020
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)