Hemodynamic Monitoring for Cardiogenic Shock
(HALO-Shock Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inova Health Care Services
Disqualifiers: Mechanical support, Pregnancy, Hospice, Infection, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization 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 data supports the effectiveness of the treatment CardioMEMS implantation for cardiogenic shock?
Research shows that the CardioMEMS device, which monitors pressure in the lungs, is effective in reducing hospitalizations and improving quality of life for heart failure patients. This suggests it could be beneficial for managing cardiogenic shock by helping doctors adjust treatments based on real-time pressure data.
12345Is the CardioMEMS device safe for humans?
The CardioMEMS device, used for monitoring heart failure, has been shown to be generally safe and reliable, though there is a risk of pulmonary artery injury during sensor placement.
23456How is the CardioMEMS HF System treatment different from other treatments for cardiogenic shock?
The CardioMEMS HF System is unique because it involves an implantable device that allows for continuous monitoring of pulmonary artery pressure, enabling more precise management of heart failure symptoms compared to traditional methods that require hospital visits for monitoring.
378910Eligibility Criteria
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).
+2 more
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.
+6 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: CardioMEMS Implant GroupExperimental Treatment1 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 GroupActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Inova Fairfax Medical CampusFalls Church, VA
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Who Is Running the Clinical Trial?
Inova Health Care ServicesLead Sponsor
AbbottIndustry Sponsor
References
Take Me Higher: A Case of Heart Failure at High Altitude Detected Using the CardioMEMS™ HF System. [2021]BACKGROUND The heart failure patient population can be challenging to treat and monitor. This is especially true when they travel to high altitudes where changes in pressure can affect their clinical status. The CardioMEMS™ HF System (Abbott Cardiovascular, Abbott Park, IL, USA) is an implanted miniature wireless device located in the pulmonary artery that transmits data on pulmonary artery pressure and heart rate. This data can be used to detect this dramatic invasive pressure change. CASE REPORT We present the case of a 78-year-old man with an exacerbation of heart failure while traveling to high altitude. Elevation of his pulmonary artery (PA) pressures were detected by his implanted CardioMEMS device. Understanding the expected change in PA pressure recordings helped to identify a true exacerbation of heart failure in our patient. This led to a prompt change in medical therapy, which ultimately prevented hospitalization. CONCLUSIONS Increased elevation can lead to falsely elevated PA pressure readings by the CardioMEMS device. However, we present the case of a patient with a disproportionate elevation of his hemodynamic pressure measurements, indicating an exacerbation of heart failure. This case demonstrates the value of the CardioMEMS device in detecting PA pressure changes in these unique circumstances.
A new option for monitoring heart failure. First experience in Spain with CardioMEMS. [2021]The CardioMEMS device is inserted into the pulmonary artery and allows monitorization of pulmonary artery pressure in heart failure patients. Previous studies have shown a reduction in hospitalizations for heart failure and an improvement in quality of life in the group of patients monitored with the device.
Translating Pressure Into Practice: Operational Characteristics of Ambulatory Hemodynamic Monitoring Program in the United States. [2023]Ambulatory hemodynamic monitoring (AHM) using an implantable pulmonary artery pressure sensor (CardioMEMS) is effective in improving outcomes for patients with heart failure. The operations of AHM programs are crucial to clinical efficacy of AHM yet have not been described.
Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. [2023]Hemodynamic-guided management with a pulmonary artery pressure sensor (CardioMEMS) is effective in reducing heart failure hospitalization in patients with chronic heart failure. This study aims to determine the feasibility and clinical utility of the CardioMEMS heart failure system to manage patients supported with left ventricular assist devices (LVADs).
Large pulmonary artery pseudoaneurysm after CardioMEMS implantation: a case report. [2022]CardioMEMS heart failure (HF) system is an implantable wireless pressure sensor that is placed in a branch of the pulmonary artery (PA) for remote monitoring of PA pressures in patients with HF. Pulmonary artery injury/haemoptysis can occur during the sensor placement.
Remote monitoring of pulmonary artery pressures with CardioMEMS in patients with chronic heart failure and NYHA class III: first experiences in the Netherlands. [2020]We report the first patient experiences with the CardioMEMS device in the Erasmus MC Thorax Center in the Netherlands. In line with clinical trial evidence, the device is applicable in patients with chronic heart failure in functional New York Heart Association class III with at least 1 admission for heart failure in the past 12 months. CardioMEMS has been shown to be safe and reliable, and effective in reducing the number of hospitalisations for heart failure by guided therapy based on pulmonary artery pressures.
Hemodynamic monitoring in heart failure and pulmonary hypertension: From analog tracings to the digital age. [2020]Hemodynamic monitoring has long formed the cornerstone of heart failure (HF) and pulmonary hypertension diagnosis and management. We review the long history of invasive hemodynamic monitors initially using pulmonary artery (PA) pressure catheters in the hospital setting, to evaluating the utility of a number of implantable devices that can allow for ambulatory determination of intracardiac pressures. Although the use of indwelling PA catheters has fallen out of favor in a number of settings, implantable devices have afforded clinicians an opportunity for objective determination of a patient's volume status and pulmonary pressures. Some devices, such as the CardioMEMS and thoracic impedance monitors present as part of implantable cardiac defibrillators, are supported by a body of evidence which show the potential to reduce HF related morbidity and have received regulatory approval, whereas other devices have failed to show benefit and, in some cases, harm. Clearly these devices can convey a considerable amount of information and clinicians should start to familiarize themselves with their use and expect further development and refinement in the future.
Monitoring Pulmonary Arterial Hypertension Using an Implantable Hemodynamic Sensor. [2022]Pulmonary arterial hypertension (PAH) is a chronic disease that ultimately progresses to right-sided heart failure (HF) and death. Close monitoring of pulmonary artery pressure (PAP) and right ventricular (RV) function allows clinicians to appropriately guide therapy. However, the burden of commonly used methods to assess RV hemodynamics, such as right heart catheterization, precludes frequent monitoring. The CardioMEMS HF System (Abbott) is an ambulatory implantable hemodynamic monitor, previously only used in patients with New York Heart Association (NYHA) class III HF. In this study, we evaluate the feasibility and early safety of monitoring patients with PAH and right-sided HF using the CardioMEMS HF System.
A wireless pressure sensor for monitoring pulmonary artery pressure in advanced heart failure: initial experience. [2007]Hemodynamic goals have been used in the past to guide therapy in patients with heart failure (HF). For HF patients whose signs and symptoms of congestion do not resolve with initial therapy it appears reasonable to consider hemodynamic monitoring at experienced sites. It has been suggested that implantable hemodynamic sensors may enable frequent monitoring of hemodynamic changes in HF patients and be used in tailoring vasodilator. We present the first human case of radio-frequency based, wireless pressure sensor for the monitoring of pulmonary artery pressure in patients with advanced HF. This sensor is delivered into the pulmonary artery via percutaneous venous access.
Initial experience with an implantable hemodynamic monitor. [2019]Measurement of intracardiac hemodynamic parameters has been limited to brief periods in the acute care setting. We developed and evaluated an implantable hemodynamic monitor that is capable of measuring chronic right ventricular oxygen saturation and pulmonary artery pressure.