Impella BTR for Heart Failure

(BTR EFS Trial)

Not currently recruiting at 6 trial locations

Overseen By Barbara Santiago

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Aortic diseases, Dialysis, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a device called Impella BTR™, designed to assist people with severe heart failure. The researchers aim to determine if this device can support the heart while patients recover or transition to other treatments. They seek participants with long-standing heart failure who currently experience severe symptoms, such as low blood pressure or the need for medications to maintain blood pressure. Those with worsening heart failure symptoms may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative heart failure research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Impella BTR is safe for patients requiring left-ventricular hemodynamic support?

Research has shown that the Impella BTR supports the heart in people with heart failure. It is smaller and less invasive than other devices used for similar purposes, potentially leading to fewer complications and quicker recovery for patients.

In studies on similar devices, patients experienced better heart function and required fewer strong medications. Although the Impella BTR is still undergoing safety testing, its design aims to reduce risks.

As this is an early feasibility study, safety remains a major focus. Researchers are closely monitoring for any side effects. So far, the device's smaller size and less invasive nature suggest it may be well-tolerated. However, more data is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Impella BTR is unique because it offers a novel approach to treating heart failure by providing temporary mechanical circulatory support. Unlike traditional treatments like medication or heart pumps that require surgery, the Impella BTR is a minimally invasive device that can be placed via a catheter. Researchers are excited because it has the potential to improve blood flow more effectively and quickly, which could lead to better patient outcomes and faster recovery times. This innovation might offer a significant advantage over current options, especially for patients who are not candidates for more invasive procedures.

What evidence suggests that the Impella BTR is effective for heart failure?

Research shows that the Impella BTR device, which participants in this trial will receive, could benefit people with heart failure. In an earlier study, similar Impella devices helped patients with severe heart failure remain stable until they could receive further treatment. Another study found that 84% of patients in critical conditions, such as severe heart problems, survived with the help of Impella devices. These results suggest that the Impella BTR can strongly support the heart and improve survival chances in challenging situations. These findings indicate that the Impella BTR may aid heart recovery or serve as a bridge to other treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

David D'Alessandro, MD

Principal Investigator

Massachusetts General Hospital

Jane Wilcox, MD MSc

Principal Investigator

Northwestern University Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe heart failure (NYHA Class IV) who are experiencing acute symptoms like low blood pressure or need devices to support their heart function. They must understand and agree to the study's terms. Excluded are those with infections, allergies to certain medications, on dialysis, severe liver or lung conditions, recent COVID-19 symptoms, prior heart surgeries within 90 days, pregnancy, mental incapacity to consent, participation in other drug/device trials that haven't reached primary endpoint yet.

Inclusion Criteria

Subject has signed the Informed Consent

Your blood pressure has stayed very low for at least 30 minutes, or you need special medication to keep your blood pressure at a safe level.

You have severe heart failure before entering the study.

Exclusion Criteria

You have an infection where the procedure will be done, or you have a suspected widespread infection.

You have a known allergy or bad reaction to heparin, pork, pork products, contrast dye, or certain study medications.

You have severe liver problems classified as Child-Pugh Class B or C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation and use of the Impella BTR™ for left-ventricular hemodynamic support

Up to 28 days

In-hospital stay for device implantation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after device removal

90 days post-implant

Regular follow-up visits to assess recovery and quality of life

What Are the Treatments Tested in This Trial?

Interventions

• Impella BTR

Trial Overview The Impella BTR™ device is being tested for its safety and effectiveness in supporting patients' hearts either towards recovery or as a bridge therapy until they can receive another treatment. This early-stage study involves participants from multiple centers who will all receive the same intervention without a comparison group.

How Is the Trial Designed?

Group I: Subjects receiving the Impella BTR Experimental Treatment 1 Intervention

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10269385/

Outcomes of surgical Impella placement in acute ... Overall, 69 patients (77%) survived to device removal, and 57 (65%) survived to hospital discharge. One-year survival was 54%. Neither etiology ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05291884

Use of the Impella BTR™ in Patients With Heart Failure ... The objectives of this Early Feasibility Study are to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support.

3. abiomed.com abiomed.com/en-us/about-us/news-and-media/press-releases/study-finds-84-survival-rate-patients-cardiogenic-shock-and-other-challenging-cardiac

Study Finds 84% Survival Rate in Patients in Cardiogenic ... The results demonstrate Impella provides dependable acute mechanical circulatory support for patients who need it by stabilizing their ...

4. withpower.com withpower.com/trial/phase-heart-failure-2-2022-2d474

Impella BTR for Heart Failure · Info for Participants Research on similar Impella devices, like the Impella 5.0, shows they can help stabilize patients with severe heart failure, allowing them to survive until they ...

5. bolderscience.com bolderscience.com/trialdetails.html?nctid=NCT05291884

Use of the Impella BTR™ in Patients With Heart Failure: An ... The objectives of this Early Feasibility Study are to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular ...

6. abiomed.com abiomed.com/en-us/about-us-/news-and-media/press-releases/worlds-first-patient-implanted-with-impella-btr-minimally-invasive-heart-pump

World's First Patient Implanted with Impella BTR Minimally ... It is smaller and less invasive than current LVADs and allows patients with chronic heart failure to have a longer-term minimally invasive heart ...

7. jhltonline.org jhltonline.org/article/S1053-2498(25)02035-2/fulltext

Clinical management of the Impella 5.5 pump This is particularly beneficial for patients with severe cardiac damage or prolonged recovery phases, offering a vital bridge to recovery (BTR) ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT05291884

Use of the Impella BTR™ in Patients With Heart Failure: An ... This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring ...