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Mechanical Circulatory Support Device
Impella CP® for Heart Attack and Cardiogenic Shock (RECOVER IV Trial)
N/A
Recruiting
Led By Navin Kapur, MD
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiogenic shock with onset ≤12 hours after STEMI and prior to index PCI, as defined by having persistent SBP <90 mmHg for ≥30 minutes despite fluid resuscitation or pressors/inotropes required to maintain SBP ≥90 mmHg and signs of impaired organ perfusion (cool extremities and/or altered mental status)
Presence of ST-segment elevation (≥2 mm elevation of ST-segments in ≥2 contiguous leads without left bundle branch block) or anterior (V1-V4) ST-segment depression ≥2 mm in ≥2 contiguous leads consistent with a possible posterior infarction AND coronary angiogram prior to randomization showing acute total or subtotal occlusion of the proximal circumflex artery or aVR ST-segment elevation ≥2 mm without anterior ST-segment elevation AND coronary angiogram prior to randomization confirming left main culprit lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all adverse events will be recorded and documented through 1 year follow up or study completion
Awards & highlights
RECOVER IV Trial Summary
This trial assesses if Impella-based support before PCI helps survival & function in STEMI-CS patients.
Who is the study for?
The RECOVER IV Trial is for patients who've had a severe type of heart attack (STEMI) leading to cardiogenic shock within the last 12 hours. They must be planning to undergo an emergency procedure to open blocked arteries (PCI), have low blood pressure despite treatment, and show signs of poor blood flow to organs. Excluded are those with certain medical conditions like prior strokes, severe infections, or life expectancy less than a year.Check my eligibility
What is being tested?
This trial tests if starting Impella CP® support before opening blocked arteries in the heart improves survival and recovery compared to standard treatments without Impella. Patients with STEMI-cardiogenic shock will either receive this device-based strategy or continue with usual care methods before their PCI procedure.See study design
What are the potential side effects?
Potential side effects from using Impella CP® include bleeding complications, issues related to vascular access such as infection or limb ischemia, possible stroke risk due to clots forming on the device, and general risks associated with heart procedures.
RECOVER IV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experienced a severe heart condition shortly after a heart attack, needing medication to maintain my blood pressure.
Select...
I have specific heart attack signs on an EKG and a confirmed blockage in my heart's arteries.
Select...
I am scheduled for an emergency procedure to treat a severe heart attack.
RECOVER IV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all adverse events will be recorded and documented through 1 year follow up or study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events will be recorded and documented through 1 year follow up or study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Other outcome measures
30-day survival with mRS score ≤3
Kidney
All Stroke
+26 moreRECOVER IV Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Subjects randomized to the Treatment Arm will receive hemodynamic support using an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI).
Group II: Control ArmActive Control1 Intervention
Subjects randomized to the Control Arm will be treated based on recommendations for cardiogenic shock in the contemporary AHA/ACC/SCAI and ESC Practice Guidelines for STEMI and Heart Failure Management and local standard of care.
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Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
33,995 Total Patients Enrolled
Navin Kapur, MDPrincipal InvestigatorTufts Medical Center
2 Previous Clinical Trials
683 Total Patients Enrolled
William O'Neill, MDPrincipal InvestigatorHenry Ford Health System
6 Previous Clinical Trials
12,302 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are already using certain devices to help your heart function.You are part of a group that may have difficulty making decisions for themselves, like people with disabilities or those living in nursing homes or homeless shelters.I have severe kidney failure and am on dialysis.I had a heart stent or bypass surgery within the last year.I have a large or moving blood clot in my heart.I have specific heart attack signs on an EKG and a confirmed blockage in my heart's arteries.I am scheduled for an emergency procedure to treat a severe heart attack.I have severe aortic valve issues or have had a valve replacement.I experienced a severe heart condition shortly after a heart attack, needing medication to maintain my blood pressure.I have heart complications from a recent heart attack that could lead to shock.I am currently on antibiotics for an infection.I am currently receiving CPR.I have had a stroke that left me with lasting significant neurological issues.I cannot follow spoken instructions after a cardiac arrest.I had COVID-19 symptoms or was hospitalized but have been symptom-free and back to my normal health for over 4 weeks.I have a very slow heart rate and am in cardiogenic shock, but I'm eligible even if I have a pacemaker.My heart's left ventricle is functioning well, above 40%.I have had a stent placed for my current heart attack.You have had a condition called heparin-induced thrombocytopenia in the past.I have had a brain bleed or have a known brain mass, aneurysm, or abnormal connection between blood vessels.I have a fast heart rate due to a specific type of irregular heartbeat.You have a strong likelihood of having a heart problem affecting the right side of your heart, confirmed by a specific test called ECG lead V4R.I have severe artery disease in both legs preventing certain heart support device insertions.I have a known aortic dissection.I do not have a severe illness that would limit my life to less than a year.I have had a stroke or doctors think I might have had one recently.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Treatment 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.
Does the eligibility criterion cover adults older than two decades of age?
"This trial will accept anyone aged 18-90 years old who meets the other requirements."
Answered by AI
What are the criteria for participating in this research program?
"To gain entry to this clinical trial, patients must be within the age range of 18-90 and demonstrate cardiogenic shock. This research project seeks 560 participants in total."
Answered by AI
Is there presently an opportunity to join this medical experiment?
"According to records on clinicaltrials.gov, this trial is no longer accepting applications as of May 5th 2023- the date it was last updated. Although recruitment has closed for this study, there are presently 486 other medical trials welcoming new participants."
Answered by AI
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