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Impella ECP Device for Heart Procedure Support
Study Summary
This trialassesses how safe Impella ECP device is for adults needing heart procedure to prevent heart and stroke complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had surgery to replace or repair my aortic valve.I am currently experiencing severe heart failure or shock.I am allergic or react badly to heparin, contrast dyes, or aspirin.I have had a stroke or brain bleed, or have a condition that increases my risk of brain bleeding.My heart condition is stable, and a team of heart specialists has recommended a specific heart procedure.I do not have an infection or fever at the surgery site or in my body.I am currently receiving dialysis.I am between 18 and 90 years old.I had COVID-19 symptoms or was hospitalized but have been symptom-free for 8 weeks.My heart valve condition may prevent safe use of a specific heart pump.I have a low platelet count or a bleeding disorder and am not open to blood transfusions.I have a known disease of the aorta or an aortic dissection.I don't have conditions that prevent the use of an Impella device due to issues with my aorta or leg arteries.
- Group 1: Impella ECP Device
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this medical experiment accept participants aged 65 and over?
"This research is currently accepting participants above the age of legal consent and below 90 years old."
Is there an ongoing recruitment process for this medical trial?
"According to the data hosted on clinicaltrials.gov, this trial is presently recruiting participants. It was first posted on December 20th 2022 and has since been revised as recently as December 23rd of that same year."
How many participants have been enlisted for this medical research?
"Affirmative. Clinicaltrials.gov asserts that this research project, which was created on December 20th 2022, is actively looking for participants. About 256 people have to be recruited from 1 clinical site."
May I sign up to join this research endeavor?
"This medical trial is searching for 256 individuals aged between 18 and 90 years old who have already undergone a percutaneous coronary intervention. The patients must be in a stable condition, with the assessment of their heart made by an expert team involving cardiac surgeons that determine this to be the best therapeutic option available. Additionally, all candidates need to provide written informed consent prior to joining the research project."
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