CONNEQT Pulse Validation Study

NCT06002971 | Terminated FDA Device

• 1 other identifier: 230608-6
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Related; Pre-Eclampsia; Gestational Hypertension

Outcome Measures

Primary Outcomes (1)

• Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.

  Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.

  Up to 60 minutes

Study Arms (3)

Normotensive

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

Device: Blood pressure measurement

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

Device: Blood pressure measurement

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

Device: Blood pressure measurement

Interventions

Blood pressure measurement DEVICE

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

Hypertensive; Normotensive; Pre-Eclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mount Carmel Health System: lead
• AtCor Medical, Inc.: collaborator

Study Sites (1)

Mount Carmel East

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: August 21, 2023
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)