Clinical trial NCT05599308: Evaluation of Blood Pressure Monitor With AFib Screening Feature
Official title: Evaluation of Blood Pressure Monitor With AFib Screening Feature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2022-10-31
Enrollment: 574
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel-cohort, open label, non-randomized study
Primary purpose: SCREENING

Brief summary: This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.


Eligibility criteria: Inclusion Criteria:

* Subjects are eligible to participate in the study if they meet all of the following criteria. AFib participants must meet criteria 1-5. non-AFib participants must meet criteria 1-3 and 6-7.

  1. Age ≥ 22 years old
  2. Arm size within 22 cm to 42 cm in circumference
  3. Participants who have an adequate understanding about the study and have given informed written consent before participation
  4. Participants who were diagnosed with AFib and have regularly seen a cardiovascular specialist
  5. Participants who have atrial fibrillation symptoms on ECG at the time of data collection
  6. Participants who have never been diagnosed with atrial fibrillation
  7. Participants who do not have AFib symptoms on ECG at data collection time

Exclusion Criteria:

* Participants will be excluded from the study if they meet any of the following criteria.

  1. Subjects who have difficulty in ECG or blood pressure measurement due to skin rashes or wounds on the chest or arm
  2. Women who are pregnant at the time of study participation.
  3. Subjects who have had a mastectomy.
  4. Subjects with pacemakers and/or defibrillators.
  5. Subjects who have difficulty in measuring blood pressure or ECG measurements in the sitting position.
  6. Subjects who are hospitalized (in-patients)
  7. Subjects whose pulse rate is less than 40 beats/minute or more than 180 beats/minute.
  8. Subjects who have had an arterio-venous shunt or an intravascular access on either arms.
  9. Subjects who have heart failure class III or IV.
  10. Subjects who at the beginning of the scheduled study time experience any of the following 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.

Primary outcomes:
measure: Sensitivity
timeFrame: 1 day
measure: Specificity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Accelacare of DuPage Medical Group
state: Illinois
city: Ames
country: United States
facility: Accelacare of MacFarland Clinic
state: Iowa
city: Charlotte
country: United States
facility: Accelacare of Charlotte
state: North Carolina
city: Wilmington
country: United States
facility: Accelacare of Wilmington
state: North Carolina
city: Charleston
country: United States
facility: Accelacare of Charleston
state: South Carolina
Study officials:
References: