Mechanical Circulatory Support for Heart Attack

(DTU-STEMI Trial)

Not currently recruiting at 75 trial locations

Overseen By Poornima Sood, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Anticoagulants, Steroids

Disqualifiers: Cardiogenic shock, Severe aortic stenosis, Pregnancy, Hepatic insufficiency, Renal replacement therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the IMPELLA® CP System, a mechanical circulatory support device, can reduce heart damage after a heart attack. The device assists the heart in pumping blood more effectively for 30 minutes before a standard procedure to open blocked arteries. Participants will receive either this device treatment or the usual care without it. Individuals who have experienced their first heart attack, specifically in the front part of the heart, and are experiencing ongoing chest pain might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart attack treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are on systemic anticoagulation (blood thinners) before the procedure. It's best to discuss your specific medications with the trial team.

What prior data suggests that the IMPELLA® CP System is safe for heart attack patients?

Research has shown that the IMPELLA® CP System, a heart pump, has been tested in various situations. In patients with cardiogenic shock, where the heart suddenly can't pump enough blood, studies found that using the Impella CP increased survival rates by 12.7% compared to those who didn't use it. Another study showed that 53.4% of patients survived until hospital discharge when the Impella CP was used.

These studies focus on serious heart conditions and demonstrate the device's successful use in real hospital settings. It's important to understand that these devices are typically used when the heart is in serious trouble, which can be risky. However, the Impella CP's use in hospitals suggests it is considered safe under proper medical supervision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMPELLA® CP System because it offers a unique approach to treating heart attacks. Unlike standard treatments that focus solely on restoring blood flow through primary percutaneous coronary intervention (PCI), the IMPELLA® CP System temporarily unloads the heart by actively supporting its pumping function before the PCI. This method could potentially reduce heart muscle damage during a heart attack, giving patients a better chance at recovery. By mechanically assisting the heart, this device may enhance outcomes and improve quality of life for those affected by severe heart attacks.

What evidence suggests that the IMPELLA® CP System is effective for reducing heart attack damage?

Research has shown that the IMPELLA® CP System can aid heart attack patients in better recovery. In this trial, participants in the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device before PCI. One study found that patients using the Impella CP heart pump had a 12.7% higher survival rate compared to those who did not use it during cardiogenic shock, a severe heart attack complication. Another study revealed that individuals using the Impella CP lived an average of 600 days longer than those receiving standard treatment. These findings suggest that the Impella CP device can significantly enhance survival and recovery for heart attack patients. ^{1 2 3 6 7}

Who Is on the Research Team?

William O'Neill, MD

Principal Investigator

Henry Ford Hospital

Norman Mangner, Prof. Dr. med. habil.

Principal Investigator

Heart Center Dresden

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who are experiencing their first heart attack and can get to the hospital within 1-6 hours of chest pain. They must be suitable for a procedure called Primary PCI and agree to participate by signing consent forms. People with severe heart valve issues, liver or kidney problems, certain lung conditions, or those in other studies can't join.

Inclusion Criteria

I arrived at the hospital within 1 to 6 hours after starting to feel chest pain.

Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent

I had a severe heart attack affecting the front part of my heart, confirmed by tests.

Exclusion Criteria

I might have an infection that is affecting my whole body.

I have not had a stroke, brain bleed, or lasting brain injury in the last 3 months.

I am on dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the IMPELLA® CP System for 30 minutes prior to catheterization procedure

Immediate

1 visit (in-person)

Post-procedure Monitoring

Infarct size evaluated using Cardiac Magnetic Resonance (CMR) imaging

3-5 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of cardiogenic shock and other clinical endpoints

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• IMPELLA® CP System

Trial Overview The study tests if using the Impella CP device before reperfusion therapy (Primary PCI) can reduce heart damage during a heart attack compared to standard immediate treatment. Participants will have this device placed for 30 minutes prior to their catheterization procedure.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Group II: Control Active Control 1 Intervention

Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Who Is Running the Clinical Trial?

Abiomed Inc.

Lead Sponsor

Trials

47

Recruited

33,900+

Founded

1981

Headquarters

Danvers, United States

Known For

Heart Recovery Technologies

Top Products

Impella heart pumps, AbioCor, Breethe OXY-1 System

Citations

1. investor.jnj.com investor.jnj.com/investor-news/news-details/2025/New-Data-from-the-DanGer-Shock-Randomized-Control-Trial-Published-in-The-New-England-Journal-of-Medicine-Confirms-the-Long-Term-Survival-Benefit-of-the-Impella-CP-Heart-Pump/default.aspx

New Data from the DanGer Shock Randomized Control Trial ... When compared to the control arm at 10 years, Impella CP patients gained an average of 600 additional days alive (95% CI: 235 – 966 days)1. The ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40846118/

Outcomes with Impella CP in Acute Myocardial Infarction ... Survival to discharge was 53.4% and was higher in HF-CS than AMI-CS (59.7% vs 49.8%; p<0.001). Those with ≥2 other devices had the lowest ...

3. heartrecovery.com heartrecovery.com/en-us/education/education-library/faq-rct-data-impella-cardiogenic-shock

RCT Data for Impella® Heart Pump Use in Cardiogenic ... The Impella CP heart pump improves survival by 12.7% compared to standard treatment without Impella in patients experiencing cardiogenic shock.

4. abiomed.com abiomed.com/en-eu/about-us/news-and-media/press-releases/rct-confirms-impella-cp-improves-survival-in-heart-attack-with-cs

Randomized Controlled Trial Confirms Impella CP ... Routine use of Impella CP in patients who have had a heart attack with STEMI cardiogenic shock reduces 180-day mortality by 12.7%, compared to the control arm.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1071916425001484

Outcomes of Surgically Implanted Impella Microaxial Flow ... Patients with HF-CS treated with Impella 5.5 had overall favorable in-hospital, 6-month and 12-month survival, both as a bridge to NHS as HRT.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002914925005569

Systematic Review and Meta-analysis of Short-Term ... Primary endpoint was all-cause mortality. Secondary outcomes were myocardial infarction, repeat revascularization, rehospitalization for heart ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06964685

Assessment of Support With Impella® Best Practices in ... This prospective, multicenter study will enroll up to 250 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute ...