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Advanced Monitoring for High Blood Pressure

N/A
Recruiting
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 45 years
Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
Must not have
Surgery for congenital heart defect
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the procedure through 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new method called the Cerebral Adaptive Index to determine personalized blood pressure targets at a single hospital.

Who is the study for?
This trial is for people aged 45 or older at high risk of stroke or other brain blood flow problems due to conditions like high blood pressure, diabetes, previous strokes, smoking, or vascular disease. They're planning heart surgery with a specific type of monitoring and have agreed to participate.
What is being tested?
The study is testing the HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring to set personalized blood pressure targets during cardiac surgery in a single-center observational pilot.
What are the potential side effects?
Since this is an observational study focusing on monitoring devices rather than medications, direct side effects from interventions are not expected. However, there may be risks associated with the use of any invasive monitoring equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 45 years old or older.
Select...
I am scheduled for heart surgery that will use a heart-lung machine.
Select...
I am scheduled for a procedure to monitor my blood pressure through a catheter.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery for a heart defect I was born with.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the procedure through 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the procedure through 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the magnitude and duration of CAI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoringExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,988 Total Patients Enrolled
~60 spots leftby May 2025