| NCT ID | NCT07148323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Hemodynamic Instability |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-10-14 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent 2. Age ≥ 18 years 3. Planned monitoring with a pulmonary artery catheter 4. Patient scheduled to undergo cardiac or liver transplant surgery lasting \> 2 hours 5. Additional criteria for Sub-Cohort A (RVF) 1. Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE) 2. Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure 6. Additional criteria for Sub-Cohort B (CAI) 1. Age ≥ 45 years 2. Planned cardiac surgery with Cardiopulmonary Bypass (CPB) 3. Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period 4. 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. Inability to provide informed consent 2. Pregnancy as confirmed per EMR 3. Patients deemed not suitable for the study at the discretion of the Investigator 4. Participation in another study that clinically interferes with the current study 5. Additional exclusion criteria for Sub-Cohort A 1. Presence of left bundle branch block 2. Presence of current/recurrent sepsis 3. Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation 4. Structural abnormality, including congenital heart defects, of the right ventricle 6. Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07148323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodynamic Instability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07148323 currently recruiting?
Yes, NCT07148323 is actively recruiting participants. Contact the research team at apmhsalta.study@bd.com for enrollment information.
Where is the NCT07148323 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07148323 clinical trial?
NCT07148323 is sponsored by Edwards Lifesciences. The trial plans to enroll 100 participants.