Impella ECP Device for Heart Procedure Support
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device, the Impella ECP, which supports the heart during high-risk procedures to open blocked blood vessels. The goal is to determine if this device can safely reduce major heart and brain-related issues. Suitable candidates have stable heart conditions and plan to undergo a specific heart procedure, but not in an emergency.
As an unphased trial, participants contribute to groundbreaking research that may enhance the safety of heart procedures.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a known allergy to heparin or other study-required medications, you may not be eligible to participate.
What prior data suggests that the Impella ECP device is safe for heart procedure support?
Research has shown that the Impella ECP device is generally safe for heart procedures. In one study, only 5.9% of patients experienced major bleeding, and just 1.6% faced other related issues. These findings suggest that most patients tolerate the device well.
Overall, the Impella ECP demonstrates promising safety results, making it a potential option for high-risk heart procedures.12345Why are researchers excited about this trial?
The Impella ECP device is unique because it offers a minimally invasive way to support the heart during procedures, unlike traditional treatments like surgical bypass or other mechanical circulatory support devices that can be more invasive. This device is inserted through a catheter, which means less trauma and potentially quicker recovery times for patients. Researchers are excited about the Impella ECP because it provides temporary support to the heart's pumping function, which could be a game-changer for patients who need cardiac support but cannot undergo more invasive procedures.
What evidence suggests that the Impella ECP device is effective for heart procedure support?
Research has shown that the Impella ECP device, which participants in this trial will receive, effectively aids heart procedures. In one study, the device successfully passed through the aortic valve in over 500 cases. It uses a small 9Fr arterial access, linked to fewer complications and high success rates. Additionally, studies on similar Impella devices have demonstrated a reduced risk of death in heart attack patients with decreased blood flow. This suggests that the Impella ECP could be a promising option for high-risk heart procedures.12345
Who Is on the Research Team?
Amir Kaki, MD
Principal Investigator
Ascension St. John Hospital
Navin Kapur, MD
Principal Investigator
Abiomed Inc.
Seth Bilazarian, MD
Principal Investigator
Abiomed Inc.
Are You a Good Fit for This Trial?
Adults aged 18-90 who need high-risk heart procedures (not emergency ones) and are stable enough for it. They must understand the study and agree to participate. People with kidney failure on dialysis, severe valve disease, blood clots in the heart, certain vessel diseases, recent strokes or bleeding in the brain, severe heart failure, or part of vulnerable groups like those with mental disabilities can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo Impella ECP placement and high-risk percutaneous coronary intervention with mechanical circulatory support
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of MACCE and other safety endpoints
What Are the Treatments Tested in This Trial?
Interventions
- Impella ECP
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abiomed Inc.
Lead Sponsor