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Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (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
No Placebo-Only Group
Summary
This trial tests if using a smartphone app to check heart rhythm regularly helps patients with atrial fibrillation take their medication more consistently.
Eligible Conditions
- Atrial Fibrillation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
anticoagulation compliance
Secondary study objectives
AF symptom severity
composite of deaths, strokes, and hospitalizations
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,691 Previous Clinical Trials
4,097,488 Total Patients Enrolled
72 Trials studying Atrial Fibrillation
1,650,920 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
Saint Luke's Health SystemLead Sponsor
41 Previous Clinical Trials
12,846 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
473 Patients Enrolled for Atrial Fibrillation
Sanjaya Gupta, MDPrincipal Investigator - Saint Luke's Health System
Anderson County Hospital, Cardiovascular Consultants PC, Hedrick Medical Center, SLCC Inc., Saint Luke's Cushing Hospital, St. Luke's East Hospital, St. Luke's Northland Hospital-Barry Rd Campus, St. Luke's South Hosital, Wright Memorial Hospital
St Louis University School Of Medicine (Medical School)
University Of Mi Hosps (Residency)
3 Previous Clinical Trials
496 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
466 Patients Enrolled for Atrial Fibrillation