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Recruiting NCT06492746

NCT06492746 Personal BP - CAI Study

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Clinical Trial Summary
NCT ID NCT06492746
Status Recruiting
Phase
Sponsor Edwards Lifesciences
Condition Blood Pressure
Study Type INTERVENTIONAL
Enrollment 120 participants
Start Date 2024-06-03
Primary Completion 2025-11

Trial Parameters

Condition Blood Pressure
Sponsor Edwards Lifesciences
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 45 Years
Max Age N/A
Start Date 2024-06-03
Completion 2025-11
Interventions
HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

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Brief Summary

A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets

Eligibility Criteria

Inclusion Criteria: 1. Signed informed consent 2. Age ≥ 45 years 3. Planned cardiac surgery with Cardiopulmonary Bypass (CPB) 4. Planned monitoring with ForeSight sensor and HemoSphere monitor 5. Planned arterial catheterization for blood pressure monitoring 6. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease Exclusion Criteria: 1. Non-English speaking 2. Confirmed to be pregnant 3. Surgery for congenital heart defect 4. Non-availability of HemoSphere with laptop CAI interface

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