Hemodynamic Monitoring for Cardiogenic Shock

(HALO-Shock Trial)

Overseen By Bhruga Shah, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Disqualifiers: Mechanical support, Pregnancy, Hospice, Infection, 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: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special device called CardioMEMS can assist individuals recently hospitalized for cardiogenic shock, a condition where the heart suddenly can't pump enough blood. The device monitors heart pressure to help doctors manage medications and treatment more effectively. Participants will either receive the CardioMEMS device or continue with standard care. Those who experience difficulty breathing with mild activity and have recently been hospitalized for cardiogenic shock might be suitable candidates. Participants must also have internet and phone access for communication. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatments for cardiogenic shock.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What prior data suggests that the CardioMEMS HF System is safe for hemodynamic monitoring in cardiogenic shock patients?

Research has shown that the CardioMEMS device is well-tolerated by people with heart failure. In past studies, patients using the CardioMEMS system experienced fewer hospital visits and improved quality of life. This device monitors heart health by tracking pressure in a major blood vessel near the heart, aiding in heart failure management.

The FDA has approved the device for heart failure patients, confirming its safety for human use. Implanting the CardioMEMS device is a quick procedure, usually taking 15 to 20 minutes, and employs standard methods that are generally well-tolerated.

Overall, the CardioMEMS system has demonstrated positive results in safely and effectively managing heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CardioMEMS implantation for cardiogenic shock because it offers a unique approach to monitoring and managing the condition. Unlike standard treatments that primarily focus on medication adjustments based on clinical symptoms and general monitoring, the CardioMEMS device allows for real-time, continuous tracking of pulmonary artery pressure. This personalized monitoring can lead to more precise medication optimization, potentially improving patient outcomes by catching issues early and preventing hospital readmissions. The ability to remotely monitor heart function outside of a hospital setting is a significant innovation, providing both patients and doctors with a proactive tool to manage cardiogenic shock more effectively.

What evidence suggests that the CardioMEMS device is effective for cardiogenic shock?

Research shows that the CardioMEMS device can significantly aid in managing heart failure, which is linked to cardiogenic shock. In this trial, participants in the CardioMEMS Implant Group will receive the device, enabling routine ambulatory pulmonary artery pressure monitoring and medication optimization. Studies have found that using this device for remote lung artery pressure monitoring reduces hospital visits for heart failure patients. Specifically, hospitalizations dropped by 46% six months after patients received the device. The device allows doctors to adjust medications based on real-time information, improving condition management. Overall, the CardioMEMS system has strong evidence of reducing complications in heart failure patients, offering promise for its use in cardiogenic shock. ^{1 2 3 4 6}

Who Is on the Research Team?

Shashank Sinha, MD MSc

Principal Investigator

Inova Fairfax Medical Campus

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who experience shortness of breath during mild activity. They must have survived a recent hospital stay due to cardiogenic shock, have internet and phone access, and be able to consent to the study. People with high procedural risks, no home discharge, pregnancy, infection, life expectancy under 6 months or on certain heart support treatments can't join.

Inclusion Criteria

I survived a hospital stay for a severe heart condition that caused low blood pressure and organ issues.

I get short of breath with light activity, despite my heart's pumping ability.

Patients must have internet and phone access (to allow communication of the implanted device with the researchers).

Exclusion Criteria

I was discharged somewhere other than an acute rehab.

If of childbearing potential with a positive pregnancy test.

I am using a device or have had a heart transplant to help my heart pump blood.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-discharge Treatment

Participants receive either the CardioMEMS device implantation or standard of care following discharge from hospitalization for cardiogenic shock

≤14 days

1 visit (in-person) for device implantation

Monitoring and Follow-up

Participants are monitored for safety and effectiveness, including health-related quality of life and NT-proBNP levels, with assessments at 2 and 6 months

6 months

Regular follow-up visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Trial Overview The trial tests if monitoring heart pressure at home using an implanted device called CardioMEMS can help manage medication better after hospitalization for cardiogenic shock compared to usual care without this device.

How Is the Trial Designed?

Group I: CardioMEMS Implant Group Experimental Treatment 1 Intervention

Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.

Group II: Non-CardioMEMS Implant Group Active Control 1 Intervention

Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.

CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization is already approved in United States for the following indications:

Approved in United States as CardioMEMS HF System for:

• NYHA Class II or III heart failure patients who have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

Ambulatory hemodynamic monitoring (AHM) using the CardioMEMS sensor has been shown to improve outcomes for heart failure patients, but its adoption is primarily limited to advanced heart failure centers, with only modest patient numbers being monitored.

Key barriers to broader implementation of AHM include patient nonadherence and inadequate insurance coverage, highlighting the need for strategies to enhance patient referral and access to this technology in community heart failure programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Pressure Into Practice: Operational Characteristics of Ambulatory Hemodynamic Monitoring Program in the United States. Bhimaraj, A., Benjamin, TA., Guglin, M., et al.[2023]

An implantable hemodynamic monitor was successfully tested in 10 patients with severe left ventricular dysfunction, allowing for chronic measurement of right ventricular oxygen saturation and pulmonary artery pressure over a follow-up period of up to 15.5 months.

The device showed reliable performance, with no significant differences in measurements compared to traditional methods, although some leads experienced dislodgment and sensor drift, indicating areas for improvement in device design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with an implantable hemodynamic monitor. Steinhaus, DM., Lemery, R., Bresnahan, DR., et al.[2019]

The CardioMEMS device has been successfully used in patients with chronic heart failure, specifically those in New York Heart Association class III, demonstrating its applicability in real-world settings.

Clinical evidence supports that the CardioMEMS device is safe and effective, significantly reducing hospitalizations for heart failure through therapy guided by monitoring pulmonary artery pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote monitoring of pulmonary artery pressures with CardioMEMS in patients with chronic heart failure and NYHA class III: first experiences in the Netherlands. Brugts, JJ., Manintveld, OC., van Mieghem, N.[2020]

In a multicenter study involving 101 patients with left ventricular assist devices (LVADs), the use of the CardioMEMS pulmonary artery pressure sensor significantly reduced pulmonary artery diastolic pressure (PAD) in responders, leading to improved walking distance and lower heart failure hospitalization rates.

Patients who maintained a PAD of less than 20 mm Hg experienced a significantly lower rate of heart failure hospitalizations (12.0%) compared to those with higher PAD levels (38.9%), highlighting the clinical utility of hemodynamic-guided management in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. Thohan, V., Abraham, J., Burdorf, A., et al.[2023]

The CardioMEMS heart failure system, while beneficial for monitoring pulmonary artery pressures, carries a risk of serious complications such as pulmonary artery injury and haemoptysis during implantation, as demonstrated in a case involving an 80-year-old patient.

In this case, a pseudoaneurysm was successfully treated with transcatheter embolization, highlighting this method as a safe and effective option for managing such complications in stable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large pulmonary artery pseudoaneurysm after CardioMEMS implantation: a case report. Garg, T., Raikhelkar, J., Gilkeson, R., et al.[2022]

Implantable hemodynamic monitoring devices, like CardioMEMS, provide valuable insights into a patient's heart failure status and can potentially reduce related health complications, supported by evidence and regulatory approval.

While some invasive methods, such as pulmonary artery catheters, are less favored now, the advancement of implantable devices offers a promising alternative for continuous monitoring of heart conditions, although not all devices have proven beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic monitoring in heart failure and pulmonary hypertension: From analog tracings to the digital age. Davey, R., Raina, A.[2020]

The CardioMEMS device was successfully implanted in 11 heart failure patients without severe complications, demonstrating its safety in a clinical setting.

Monitoring pulmonary artery pressure with the CardioMEMS device allowed for precise adjustments in medical treatment, resulting in very few heart failure readmissions, indicating its efficacy in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new option for monitoring heart failure. First experience in Spain with CardioMEMS. Codina, P., Altisent, OA., Santiago-Vacas, E., et al.[2021]

The CardioMEMS™ HF System effectively detects changes in pulmonary artery pressure in heart failure patients, even in challenging conditions like high altitudes, as demonstrated in a case study of a 78-year-old man.

In this case, the device helped identify a true exacerbation of heart failure, allowing for timely medical intervention that prevented hospitalization, showcasing its potential for improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Take Me Higher: A Case of Heart Failure at High Altitude Detected Using the CardioMEMS™ HF System. Letourneau, MM., Brancheau, D., Estes, J., et al.[2021]

The CardioMEMS HF System was safely implanted in 26 patients with pulmonary arterial hypertension (PAH) and right-sided heart failure, showing no serious device-related adverse events and only one pre-implant serious adverse event.

Monitoring with the CardioMEMS HF System led to significant reductions in pulmonary artery pressure and improvements in cardiac output, NYHA class, and quality of life within one year, indicating its potential effectiveness in managing PAH therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Pulmonary Arterial Hypertension Using an Implantable Hemodynamic Sensor. Benza, RL., Doyle, M., Lasorda, D., et al.[2022]

The study introduces the first human case of a wireless, radio-frequency based pressure sensor designed to monitor pulmonary artery pressure in patients with advanced heart failure, which could improve management of their condition.

This implantable hemodynamic sensor allows for continuous monitoring, potentially enabling more tailored treatment strategies for heart failure patients whose symptoms do not improve with standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wireless pressure sensor for monitoring pulmonary artery pressure in advanced heart failure: initial experience. Castro, PF., Concepción, R., Bourge, RC., et al.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843804/

CardioMEMS Heart Failure System: An Up-to-Date Review The study confirmed significant reductions in HF hospitalizations, affirming the device's efficacy outside controlled trial environments.

2. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/heart-failure/pulmonary-pressure-monitors/cardiomems/clinical-evidence.html

CardioMEMS HF System Clinical Evidence The CardioMEMS™ HF System for remote pulmonary pressure monitoring has demonstrated significant clinical benefits in a variety of clinical studies and trial ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100045S056B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The CardioMEMS™ HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures ...

4. icer.org icer.org/wp-content/uploads/2020/10/CHF_Revised_Draft_Report_100915.pdf

CardioMEMS™ HF System (St. Jude Medical) and 16,50 We utilized the results from the PARADIGM-HF trial to estimate numbers of CHF hospitalizations, costs, deaths, life-years, and quality-adjusted life years ...

5. innovationsincrm.com innovationsincrm.com/latest-news/998-cardiomems-hf-system

Late-Breaking Data Shows the CardioMEMS HF System is ... Researchers found a 46 percent reduction in heart failure hospitalizations in patients six months after receiving the CardioMEMS HF System, and a 34 percent ...

6. citoday.com citoday.com/articles/2018-jan-feb/how-to-implant-the-cardiomems-heart-failure-sensor

How to Implant the CardioMEMS Heart Failure Sensor Implantation can be safely performed using standard percutaneous techniques in approximately 15 to 20 minutes and should always include complete RHC with ...