Abiomed Impella RT-DAQ - Observational Study
This research study, called 'Abiomed Impella RT-DAQ', is exploring how to better measure heart function in people experiencing cardiogenic shock. Cardiogenic shock is a serious condition where the heart can't pump enough blood to meet the body's needs. The study uses a special heart pump called Impella, along with other sensors, to collect real-time information about how the heart is working. The main goal is to develop new computer programs that can figure out how much blood the heart is pumping (called cardiac output) without needing more invasive procedures in the future. By carefully gathering this data, researchers hope to improve how doctors monitor and care for patients with this severe heart problem.
At a glance
What is this study about?
This study is called 'Abiomed Impella RT-DAQ,' and it's focusing on a very serious heart problem known as cardiogenic shock. This happens when your heart suddenly can't pump enough blood to keep your body running properly. Doctors often use a special device called an Impella pump to help the heart in these situations.
The main idea behind this study is to find smarter and less invasive ways to understand exactly how well your heart is pumping. Currently, doctors might need to use tubes placed inside your body to measure this. The study hopes to use the Impella pump itself, along with other sensors that measure pressure, to collect lots of information about your heart's activity. By doing this, they want to create computer programs that can accurately tell doctors how much blood your heart is pumping (this is called 'cardiac output') without needing those more invasive procedures in the future.
Ultimately, the goal is to make monitoring heart function easier and safer for patients in critical condition. If successful, this research could lead to improved care for people with cardiogenic shock, helping doctors make faster and better decisions about treatment.
Key takeaways
- The study aims to find better, less invasive ways to monitor heart function.
- It focuses on patients with a serious heart condition called cardiogenic shock.
- Researchers will collect data from existing medical devices like the Impella pump.
- No new treatments or procedures are given as part of this study.
- Your medical care will not be changed by participating.
- Your data could help improve care for future patients.
Who may be eligible?
To be considered for this study, you would need to be in an intensive care unit (ICU) and either already have an Impella heart pump helping your heart, or be about to have one put in. Importantly, your heart function would also need to be measured as part of your care, either through a special catheter (a thin tube) in your pulmonary artery, or using other methods like an ultrasound scan of your heart or another specialized test.
There are also some reasons why you wouldn't be able to join the study. You must be at least 18 years old – people under 18 cannot take part. If you are pregnant, or if it's expected that you will only need the Impella pump for less than 24 hours, then you also wouldn't be able to participate. This study is open to both men and women.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you currently receiving care in an intensive care unit (ICU)?
- Do you currently have an Impella heart pump, or are you about to have one placed?
- Are your doctors already measuring your heart's pumping ability (cardiac output)?
- Are you not pregnant?
- Is it expected that you will need the Impella pump for at least 24 hours?
What does participation involve?
If you join this study, it's important to understand that no new treatments or medications will be given to you. The study is purely observational, meaning researchers will be collecting data from the Impella pump and other standard monitoring equipment you already have as part of your normal hospital care. They will also gather information from any heart function measurements your doctors are already taking.
This simply means they will be collecting information that is already available to your medical team. You won't have extra visits or assessments specifically for the study. Your involvement would continue for as long as you are receiving Impella support and heart function monitoring, and the total duration would depend on your individual medical needs. There are no additional follow-up appointments required specifically because of your participation in this study.
Potential risks and benefits
Locations (5)
- Uniklinik RWTH AachenVerified postcodeAachen, Germany
- UKSH Campus KielVerified postcodeKiel, Germany
- Asklepios Klinik AltonaVerified postcodeHamburg, Germany
- IRCCS Ospedale San RaffaeleVerified postcodeMilan, Italy
- Universitätsspital BaselVerified postcodeBasel, Switzerland
Common questions
What is cardiogenic shock?
Cardiogenic shock is a serious medical emergency where your heart suddenly can't pump enough blood to meet your body's needs.
What is an Impella pump?
An Impella pump is a very small heart pump that doctors use to help your heart circulate blood when it's struggling.
Will I receive new treatments in this study?
No, this study is 'observational,' meaning researchers will only collect data from your standard medical care, not give you new treatments.
Will participating affect my hospital care?
No, your participation will not change the medical care you receive from your doctors and nurses.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it will not affect your medical treatment or care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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