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Alive Cor Kardia mobile electrocardiogram monitor for Atrial Fibrillation (BOAT OAR Trial)

N/A
Waitlist Available
Led By Sanjaya Gupta, MD
Research Sponsored by Sanjaya Gupta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

BOAT OAR Trial Summary

This trial is looking at whether or not mobile health tools can help improve compliance of anticoagulant medication in patients with atrial fibrillation in order to reduce the risk of stroke.

Eligible Conditions
  • Atrial Fibrillation

BOAT OAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
anticoagulation compliance
Secondary outcome measures
AF symptom severity
composite of deaths, strokes, and hospitalizations

BOAT OAR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
In the experimental group, each patient will be issued an AliveCor Kardia electrocardiogram monitor that is compatible with their smartphone. Patients will be instructed on the use of the monitor at the initial visit with the study nurse. The patient will submit daily electrocardiogram transmission via on online portal. The study nurse may contact them via text message to remind them to submit their recordings, if they forget. The remainder of the treatment of the experimental group will be identical to the control group. At the conclusion of the study, the patient will complete their final atrial fibrillation symptom assessment scale. Their smartphone electrocardiogram monitor will be reviewed to ensure that all of the recordings were retrieved successfully.
Group II: ControlActive Control1 Intervention
Patients in the control group would receive the standard of care treatment for atrial fibrillation, including cardioversion and ablation as indicated. At monthly visits with the study nurse, a smartphone electrocardiogram monitor will be used to record patient's heart rhythm. No other intervention would be performed during the monthly visit. It is necessary to meet the subject at least once per month to receive the previous month's supply of pills and provide them with the next month's supply of pills. If these subjects were met less frequently, it is possible that the previous month's supply of pills might be lost by the end of the study. During the study, if the patient is taken off anticoagulation due to medical contraindication or after an ablation, they will continue to be followed monthly but will not receive apixaban medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alive Cor Kardia mobile electrocardiogram monitor
2017
N/A
~100

Find a Location

Who is running the clinical trial?

Sanjaya GuptaLead Sponsor
2 Previous Clinical Trials
464 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
434 Patients Enrolled for Atrial Fibrillation
Bristol-Myers SquibbIndustry Sponsor
2,651 Previous Clinical Trials
4,130,471 Total Patients Enrolled
72 Trials studying Atrial Fibrillation
1,646,420 Patients Enrolled for Atrial Fibrillation
AliveCorIndustry Sponsor
4 Previous Clinical Trials
1,210 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
160 Patients Enrolled for Atrial Fibrillation
~13 spots leftby Jun 2025