CONNEQT Pulse Validation Study

NCT ID: NCT06002971

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-21

Study Completion Date

2025-06-03

Brief Summary

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The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.

Detailed Description

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Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.

Conditions

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Pregnancy Related Pre-Eclampsia Gestational Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normotensive

Normotensive pregnant patients beyond the first trimester with systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg

Blood pressure measurement

Intervention Type DEVICE

Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Hypertensive

Hypertensive pregnant patients beyond the first trimester:

i) without proteinuria \>300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg

Blood pressure measurement

Intervention Type DEVICE

Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Pre-Eclampsia

Pre-eclampsia patients beyond the first trimester:

i) with proteinuria \>300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg

Blood pressure measurement

Intervention Type DEVICE

Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Interventions

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Blood pressure measurement

Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All Groups:

1. Able to provide informed consent
2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
3. 18 years of age, or older

Normotensive:

1\. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa)

Hypertensive:

1. Without proteinuria \>300 mg in 24 h; and
2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)

Pre-Eclampsia:

1. With proteinuria \>300 mg in 24 h; and
2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AtCor Medical, Inc.

INDUSTRY

Sponsor Role collaborator

Mount Carmel Health System

OTHER

Sponsor Role lead

Responsible Party

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Robin Driver

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mount Carmel East

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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230608-6

Identifier Type: -

Identifier Source: org_study_id

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