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Impella ECP Device for High-Risk Heart Procedures (ECP EFS Trial)
ECP EFS Trial Summary
This trial is testing how safe and effective the Impella ECP device is for people undergoing a high-risk heart procedure.
ECP EFS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ECP EFS Trial Design
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Who is running the clinical trial?
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- You have a known condition affecting the blood vessels in your aorta or have experienced a tear in your aorta.You have a problem with your heart's aortic valve that would make it difficult for a device called Impella ECP to be inserted, especially if your aortic stenosis is severe.You have an infection at the area where the procedure will be done, or you have signs of a widespread infection like a fever.You have had surgery to replace or repair your aortic valve in the past.
- Group 1: Subjects receiving the Impella ECP
- 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
Is the eligibility criterion for this experiment limited to individuals over eighteen years of age?
"Eligible participants for this trial must be of legal age (18+) and younger than 90 years old."
Is there an opportunity to participate in this experiment?
"Eligibility for this trial hinges on the patient having received a percutaneous coronary intervention and falling within the age bracket of 18 to 90. A total of one hundred individuals are expected to be enrolled in the study."
What are the intended outcomes of this investigation?
"The primary goal of this clinical trial, which is to be conducted over the course of one day and evaluated at its conclusion, is assessing the feasibility of successful hemodynamic support. Secondary objectives include gauging the rate of major device-related adverse events, evaluating technical success with regards to Impella ECP delivery procedure completion and pump initiation without malfunctioning equipment, as well as determining procedural success by measuring sufficient blood flow generation in order to increase or maintain MAP during intervention."
What is the current enrollment capacity for this clinical investigation?
"Affirmative. According to clinicaltrials.gov, the trial is currently recruiting participants and was first revealed on October 9th 2020. The most recent update was made on September 15 2022 and 100 individuals are needed from a single study site."
Are there any available slots for individuals to partake in this trial?
"Affirmative. According to clinicaltrials.gov, the medical trial is still actively recruiting patients after being posted on October 9th 2020 and last updated September 15th 2022. The study aims to include 100 individuals at one particular site."
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