Advanced Monitoring for High Blood Pressure

Overseen By Cristina Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Non-English speaking, Pregnant, Congenital heart defect, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of the procedure

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method for monitoring and personalizing blood pressure goals in patients undergoing heart surgery. It employs the HemoSphere Advanced Monitoring Platform with the Acumen IQ sensor and Tissue Oximetry Monitoring to track blood pressure and oxygen levels. Designed for individuals over 45 years old who plan to undergo heart surgery involving a heart-lung machine, it targets those with a history of conditions like high blood pressure, diabetes, or past strokes. Participants should prepare for specific monitoring and procedures during their surgery. This study could improve blood pressure management during heart surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the HemoSphere Advanced Monitoring Platform is safe for cardiopulmonary bypass patients?

Research has shown that the HemoSphere Advanced Monitoring Platform, which uses the Acumen IQ sensor and Tissue Oximetry Monitoring, is generally well-tolerated. In past studies, this platform provided real-time information about blood pressure and blood flow without reporting any major side effects, suggesting its safety for people.

The platform detects changes in blood flow and pressure, crucial for patients undergoing procedures like heart-lung bypass surgery. Although the studies do not offer detailed safety data, the use of this technology in medical settings indicates it is reasonably safe.

If the platform were unsafe, it likely wouldn't be used in these environments. However, patients should always consult their healthcare provider to understand how this monitoring tool fits into their personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring because it could change how we monitor blood pressure and oxygen levels during cardiopulmonary bypass surgery. Unlike traditional blood pressure cuffs and pulse oximeters, this advanced monitoring system offers real-time, continuous data. This means it can provide more precise and timely information, potentially leading to better patient outcomes during complex surgeries. By offering a more dynamic view of a patient’s status, this technology may help doctors make quicker, more informed decisions.

What evidence suggests that the HemoSphere Advanced Monitoring Platform is effective for high blood pressure?

Research shows that the HemoSphere Advanced Monitoring Platform, combined with the Acumen IQ sensor and Tissue Oximetry Monitoring, effectively manages blood pressure. In this trial, participants undergoing cardiopulmonary bypass will receive blood pressure and oximetry monitoring through this platform. The platform's smart technology detects blood pressure changes early, enabling doctors to address potential issues before they escalate. Studies have shown that it improves blood flow by providing real-time information about a patient's condition. This monitoring proves especially helpful for patients undergoing complex procedures like heart-lung bypass surgery, where maintaining stable blood pressure is crucial. Overall, evidence supports its potential to enhance blood pressure management in these patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 45 years old or older.

I am scheduled for heart surgery that will use a heart-lung machine.

I am at high risk for stroke or brain blood vessel issues due to conditions like high blood pressure, diabetes, or smoking.

Exclusion Criteria

Non-availability of HemoSphere with laptop CAI interface

I have had surgery for a heart defect I was born with.

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiopulmonary bypass with blood pressure and oximetry monitoring

Duration of the procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

Trial Overview 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.

How Is the Trial Designed?

Group I: Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

The LifeGuard system, developed by NASA Ames Research Center and Stanford University, is a lightweight and unobtrusive wearable device designed to monitor vital signs in real-time, making it suitable for mobile applications like space missions and healthcare.

This system is capable of logging vital signs for several hours and transmitting data securely, which enhances its usability for various fields, including clinical settings, home health monitoring, and military operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifeguard--a personal physiological monitor for extreme environments. Montgomery, K., Mundt, C., Thonier, G., et al.[2020]

Non-invasive monitoring technologies, like pulse oximetry for measuring hemoglobin levels (SpHb), provide continuous and unobtrusive data that can be transmitted directly to caregivers, enhancing patient safety.

The study confirms that SpHb's trend accuracy can prompt earlier laboratory testing for hemoglobin levels, allowing for timely identification of issues like postoperative bleeding, which can prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive monitoring is coming the full circle, making our patients safer! Ramsay, MA.[2021]

In a study involving 14 patients undergoing hemodialysis, it was found that the relative blood volume change (DeltaRBV) measurements from three different devices (Hemoscan, Crit-Line, and BVM) differed significantly from those calculated using laboratory-derived hemoglobin changes, indicating potential inaccuracies in device measurements.

The comparison of DeltaRBV results among the devices revealed substantial discrepancies, with significant differences noted between the Hemoscan and Crit-Line devices, suggesting that the choice of monitoring device could impact the management of hemodialysis hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative blood volume measurements during hemodialysis: comparisons between three noninvasive devices. Dasselaar, JJ., Huisman, RM., DE Jong, PE., et al.[2007]

In a study involving 583 patients across 27 cardiology practices, the ZOLL Arrhythmia Monitoring System, which combines ECG data with additional biometric information, led to treatment plan changes in 96% of cases, demonstrating its significant impact on patient management.

The integration of biometric data allowed for modifications in medications, follow-up, and lifestyle changes for 64% of patients, suggesting that this next-generation monitoring system enhances the ability of physicians to assess cardiovascular risks and improve overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation Mobile Cardiac Telemetry: Clinical Value of Combining Electrocardiographic and Physiologic Parameters. Yoo, D., Bhalla, K., Manyam, H., et al.[2022]

The HemoCue Hb 201+ is a portable device that allows for quick and accurate measurement of hemoglobin levels from various blood sources, which is crucial for monitoring patients in dialysis units.

In a study involving 148 hemoglobin measurements, the device demonstrated its effectiveness, providing flexibility for outpatient dialysis centers to manage patient care and erythropoietin treatment more efficiently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HemoCue: preliminary considerations about its use in hemodialysis]. Montagnac, R., Vitry, F., Rehn, Y., et al.[2007]

The Biomon-HF project developed and tested innovative sensors for monitoring vital signs during sleep in 115 heart failure patients, showing promise for personalized telemonitoring and therapy management.

These sensors can help detect heart failure exacerbations and related health issues early, potentially reducing complications and healthcare costs while improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". Vollmer, T., Schauerte, P., Zink, M., et al.[2015]

The CardioMEMSTM HF system is a wireless monitoring tool that tracks pulmonary artery pressure, allowing healthcare providers to detect early signs of heart failure decompensation and adjust treatments promptly, which can help prevent rehospitalization.

Data from trials and registries indicate that using the CardioMEMSTM system is associated with reduced heart failure hospitalization rates and improved quality of life, making it a safe and cost-effective option for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CardioMEMSTM System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation. Mangi, MA., Nesheiwat, Z., Kahloon, R., et al.[2022]

In a study comparing two ambulatory blood pressure monitors, the Spacelabs device recorded significantly higher systolic blood pressure readings than the Mobil-O-Graph, with differences of 10.2 mm Hg in nonrandomized and 7.9 mm Hg in randomized settings.

The mean arterial pressures were only slightly different (1-2 mm Hg) between the two devices, while heart rates measured were nearly identical, suggesting that while systolic readings vary, overall heart rate monitoring may be consistent across devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two ambulatory blood pressure monitors worn at the same time. Kallem, RR., Meyers, KE., Sawinski, DL., et al.[2021]

In the CHAMPION trial, patients with ambulatory pulmonary artery pressure (PAP) monitoring showed significantly lower rates of heart failure hospitalizations (HFH) and all-cause readmissions within 30 and 90 days after hospitalization, indicating improved management of heart failure.

A retrospective analysis of 459 patients revealed a 45% reduction in 90-day all-cause readmission rates post-PAP sensor implantation, demonstrating the effectiveness of this monitoring approach in enhancing patient outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in 90 day readmission rates utilizing ambulatory pulmonary pressure monitoring. Valika, A., Sulemanjee, N., Pedersen, R., et al.[2023]

Remote hemodynamic monitoring using the CardioMEMS HF system allows for early detection of heart failure by measuring pulmonary artery pressures, which can help prevent hospitalizations by enabling timely interventions.

Clinical evidence supports the efficacy and safety of the CardioMEMS system, highlighting its potential as a valuable tool in managing chronic heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CardioMEMS™: a tool for remote hemodynamic monitoring of chronic heart failure patients. Radhoe, SP., Brugts, JJ.[2022]

The Spacelabs 90207 model for non-invasive blood pressure monitoring has been validated as effective, meeting the standards set by the British Hypertension Society and the Association for the Advancement of Medical Instrumentation.

In a study involving 90 participants, the Spacelabs 90207 showed comparable blood pressure readings to traditional manual measurements, indicating its reliability for monitoring blood pressure in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of Spacelabs 90207, the noninvasive automatic monitor for ambulatory monitoring of blood pressure]. Márquez Contreras, E., López de Andrés, M., Casado Martínez, JJ., et al.[2016]

The CardioMEMSTM system, which continuously monitors pulmonary arterial pressure (PAP) in heart failure patients, has been shown to significantly reduce hospitalizations related to heart failure and overall mortality.

Access to real-time hemodynamic data from the CardioMEMSTM device allows for timely adjustments in medical therapy, leading to earlier interventions such as left ventricular assist device implantation and shorter wait times for heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory pulmonary artery pressure monitoring in advanced heart failure patients. Yandrapalli, S., Raza, A., Tariq, S., et al.[2020]

A study comparing three software versions of the SpaceLabs model 90202 blood pressure monitor found that unannounced software updates can significantly affect mean arterial pressure (MAP) measurements, with the latest version showing a 5.4 mmHg increase in MAP compared to older versions.

The findings highlight the importance of using the same monitor for each patient in clinical trials to ensure reliable blood pressure readings, as even monitors with the same software version can yield different results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A plea for consistent reliability in ambulatory blood pressure monitors: a reminder. Hansen, KW., Orskov, H.[2019]

Recent advancements in ambulatory blood pressure monitoring devices have led to improvements in their design, making them lighter, quieter, and more accurate for intermittent measurements.

While newer devices like the SpaceLabs 90202 and 90207 show some inaccuracies, they effectively capture hour-to-hour blood pressure changes that closely resemble those from invasive methods, allowing for a more accurate 24-hour blood pressure profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the accuracy of blood pressure monitoring devices in ambulatory conditions. Parati, G., Groppelli, A., Omboni, S., et al.[2007]

The SpaceLabs 90207 monitor demonstrated a high level of accuracy in measuring blood pressure, with mean differences of only 1.59 mmHg for systolic and 1.05 mmHg for diastolic blood pressure compared to the mercury sphygmomanometer, based on a study of 86 patients.

The monitor met the British Hypertension Society's validation criteria, achieving grade B for most blood pressure measurements, indicating it is a reliable tool for outpatient blood pressure monitoring, although it showed some limitations in patients over 65 years for systolic readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An evaluation of the Spacelabs 90207 model of the ambulatory arterial pressure monitoring system]. Mayoral Sánchez, E., Díez Naz, AD., Lapetra Peralta, J., et al.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07148323

Study Details | NCT07148323 | HemoSphere Alta Study Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices, Number of patients who receive monitoring using ...

2. bd.com bd.com/en-us/products-and-solutions/products/product-families/hemosphere-alta-monitor

HemoSphere Alta™ Monitor Purpose-built for smart and predictive parameters, HemoSphere Alta™ Monitor is designed to help you detect hemodynamic instability before it occurs—so you can ...

3. eifu.edwards.com eifu.edwards.com/eifu/5970f1b346e0fb00015e5f4d/DOC-0251933A.pdf

HemoSphere Alta Advanced Monitoring Platform The Edwards HemoSphere Alta advanced monitoring platform operator's manual is comprised of 14 chapters and 7 appendices. Figures in this manual are intended for ...

4. edwards.com edwards.com/healthcare-professionals/products-services/hemodynamic-monitoring/hemosphere-alta

HemoSphere Alta monitor A modern approach to hemodynamic management that enables you to monitor patient trends interventions and alerts from one high-resolution, customizable screen.

5. mpo-mag.com mpo-mag.com/breaking-news/bd-releases-hemosphere-alta-ai-powered-hemodynamic-monitoring-tech/

BD Releases HemoSphere Alta Hemodynamic Monitoring ... HemoSphere Alta's AI-based algorithms help proactively address blood pressure instability and optimize blood flow.

6. xtalks.com xtalks.com/hemosphere-alta-by-bd-brings-ai-driven-hemodynamic-monitoring-4205/

HemoSphere Alta by BD Brings AI-Driven Hemodynamic ... The HemoSphere Alta platform features the Cerebral Autoregulation Index, which helps personalize blood pressure targets in real time.