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Impella-Supported PCI for Coronary Heart Disease (PROTECT IV Trial)
N/A
Recruiting
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
OR B. Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment.
Age ≥18 years and ≤90 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
PROTECT IV Trial Summary
This trial will test if using a heart pump called Impella during high-risk heart procedures helps improve symptoms, heart function, and health better than the current standard of care.
Who is the study for?
Adults aged 18-90 with complex coronary artery disease, reduced left ventricular function (LVEF ≤40% or ≤30% in specific cases), and planned high-risk PCI. Candidates must not have life-threatening non-cardiac conditions, recent severe heart attacks, cardiogenic shock, pregnancy, or other serious medical issues that could affect participation.Check my eligibility
What is being tested?
The trial is testing whether using the Impella® devices during high-risk percutaneous coronary intervention (PCI) improves symptoms and heart function compared to standard care with an intra-aortic balloon pump in patients with significant heart vessel blockage and weakened heart pumping ability.See study design
What are the potential side effects?
Potential side effects of using Impella® devices may include bleeding at the catheter insertion site, blood vessel damage, irregular heartbeat, blood clots leading to stroke or other problems; however individual experiences can vary.
PROTECT IV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a severe heart attack between 1 to 30 days ago and my heart's pumping ability is very weak.
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I am between 18 and 90 years old.
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I have severe blockages in all three main heart arteries and plan to have stent placement in at least two.
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My heart's pumping ability is reduced due to a recent heart attack.
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I had a procedure on my last unblocked heart vessel.
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I have severe blockages in the main arteries of my heart that need treatment.
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My heart team has recommended a procedure to open my heart's blocked arteries.
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I am scheduled for a complex PCI procedure.
PROTECT IV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The composite of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular (CV) causes.
Secondary outcome measures
6MWD
Achievement of complete anatomic revascularization after the index and planned staged procedures
All CV hospitalizations through 3 years
+5 morePROTECT IV Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Impella ArmExperimental Treatment1 Intervention
Impella CP® or Impella 2.5 placement prior to high-risk PCI
Group II: Control ArmActive Control1 Intervention
Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).
Find a Location
Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
33,303 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
868 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a severe heart attack between 1 to 30 days ago and my heart's pumping ability is very weak.I do not have severe heart, blood, or vascular conditions that would exclude me.I am between 18 and 90 years old.I have a specific type of heart blockage and plan to have surgery on it and two other areas.I have severe blockages in all three main heart arteries and plan to have stent placement in at least two.I had a severe heart attack within the last 24 hours or have complications from a heart attack.My heart team has recommended a procedure to open my heart's blocked arteries.I have a non-heart related condition that may shorten my life to under 3 years.I tested positive for COVID-19 recently but have not felt sick.My heart's pumping ability is reduced due to a recent heart attack.I had a heart or lung stoppage but have been stable and fully conscious for over 24 hours after being taken off a ventilator.I had COVID-19 symptoms or was hospitalized but have been symptom-free and back to my normal health for at least 4 weeks.I am currently in the hospital for COVID-19.I had a procedure on my last unblocked heart vessel.I have CCS or NSTEMI and my heart's pumping ability is 40% or less.I have severe blockages in the main arteries of my heart that need treatment.You are currently using a breathing tube, or have used one recently during your hospital stay.I can have an Impella device placed in my arteries without issues.I have experienced a severe heart condition known as cardiogenic shock.My heart team has recommended a procedure to open my heart's blocked arteries.I am scheduled for a complex heart procedure due to severe artery disease.I am scheduled for a complex PCI procedure.You must meet certain criteria related to your heart function.
Research Study Groups:
This trial has the following groups:- Group 1: Impella Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to join this experiment at present?
"Clinicaltrials.gov confirms that this trial is actively recruiting participants from its initial posting on April 13th 2021 to the most recent update on November 16th 2022."
Answered by AI
Does this trial take on subjects of legal majority age?
"According to the stated eligibility requirements, this clinical trial is open to participants who are between 18 and 90 years old. There are 25 studies for those under 18 and 597 studies available for seniors aged 65 or more."
Answered by AI
Are there certain characteristics that would make an individual an ideal candidate for this experiment?
"This healthcare trial is seeking 1252 patients, aged 18 to 90, who have been diagnosed with coronary artery disease. Participants must meet the following criteria: Possession of certain clinical presentation and baseline left ventricular function parameters (2A or 2B), PCI has been deemed by a local heart team as the most suitable management option for them, Age between 18-90 years old, Intervention required in last remaining vessel (native coronary artery/bypass graft) OR Left main equivalent disease with both ostial LAD and LCX having visually assessed angiographic DS ≥80% [or ≥40% if there's non-invasive evidence"
Answered by AI
How many individuals are currently enrolled in this clinical experiment?
"To complete this trial, 1252 subjects that meet the prerequisites must enroll. Individuals can sign up at Washington Regional Medical Center - Walker Heart Institute in Fayetteville, Arkansas and Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants in Coon Rapids, Minnesota."
Answered by AI
How many medical facilities are actively conducting this experiment?
"Currently, 89 medical centres across the country are hosting this clinical trial. Among them are Fayetteville, Coon Rapids and Detroit along with other sites. To reduce commuting times for participants, it is advisable to select a nearby location when enrolling in the study."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
New Jersey
How old are they?
18 - 65
What site did they apply to?
Arkansas Cardiology
Washington Regional Medical Center - Walker Heart Institute
Robert Wood Johnson Medical School & Robert Wood Johnson University Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
When will screening start?
PatientReceived no prior treatments
Why did patients apply to this trial?
Seems like a novel way to help with my heart issues.
PatientReceived 2+ prior treatments
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