Last updated: April 27, 2023
Sponsor: Omron Healthcare Co., Ltd.
Overall Status: Completed
Phase
N/A
Condition
Chest Pain
Arrhythmia
Atrial Fibrillation
Treatment
N/AClinical Study ID
NCT05599308
HDV-CTD-210151
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects are eligible to participate in the study if they meet all of the followingcriteria. AFib participants must meet criteria 1-5. non-AFib participants must meetcriteria 1-3 and 6-7.
- Age ≥ 22 years old
- Arm size within 22 cm to 42 cm in circumference
- Participants who have an adequate understanding about the study and have giveninformed written consent before participation
- Participants who were diagnosed with AFib and have regularly seen acardiovascular specialist
- Participants who have atrial fibrillation symptoms on ECG at the time of datacollection
- Participants who have never been diagnosed with atrial fibrillation
- Participants who do not have AFib symptoms on ECG at data collection time
Exclusion
Exclusion Criteria:
- Participants will be excluded from the study if they meet any of the followingcriteria.
- Subjects who have difficulty in ECG or blood pressure measurement due to skinrashes or wounds on the chest or arm
- Women who are pregnant at the time of study participation.
- Subjects who have had a mastectomy.
- Subjects with pacemakers and/or defibrillators.
- Subjects who have difficulty in measuring blood pressure or ECG measurements inthe sitting position.
- Subjects who are hospitalized (in-patients)
- Subjects whose pulse rate is less than 40 beats/minute or more than 180beats/minute.
- Subjects who have had an arterio-venous shunt or an intravascular access oneither arms.
- Subjects who have heart failure class III or IV.
- Subjects who at the beginning of the scheduled study time experience any of thefollowing newly developed conditions within the past 3 hours: chest pain,paralysis or numbness (face, arm or leg), trouble speaking or understanding,visual field loss in one or both eyes.
Study Design
Total Participants: 574
Study Start date:
September 06, 2022
Estimated Completion Date:
April 11, 2023
Connect with a study center
Accelacare of DuPage Medical Group
Winfield, Illinois 60190
United StatesSite Not Available
Accelacare of MacFarland Clinic
Ames, Iowa 50010
United StatesSite Not Available
Accelacare of Charlotte
Charlotte, North Carolina 28209
United StatesSite Not Available
Accelacare of Wilmington
Wilmington, North Carolina 28401
United StatesSite Not Available
Accelacare of Charleston
Charleston, South Carolina 29464
United StatesSite Not Available

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