Impella BTR for Heart Failure

(BTR EFS Trial)

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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a small heart pump in adults who need help with their heart's pumping function. The pump helps move blood from the heart to the body, giving the heart a chance to rest and recover.

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 data supports the effectiveness of the treatment Impella BTR for heart failure?

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 can receive further treatment, such as a heart transplant or a more permanent heart support device. In one study, 75% of patients using the Impella 5.0 survived to receive their next therapy. ^{1 2 3 4 5}

How does the Impella BTR treatment for heart failure differ from other treatments?

The Impella BTR is a unique treatment for heart failure as it is a minimally invasive device that provides temporary mechanical circulatory support, helping the heart pump blood more effectively. Unlike traditional drug therapies, it is a percutaneous (through the skin) device that can stabilize patients with severe heart failure, offering a bridge to more permanent solutions like heart transplants or long-term mechanical support. ^{3 4 6 7 8}

Research Team

David D'Alessandro, MD

Principal Investigator

Massachusetts General Hospital

Jane Wilcox, MD MSc

Principal Investigator

Northwestern University Hospital

Eligibility Criteria

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

Age ≥18 years

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.

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Initial experience covering 50 consecutive cases of large Impella implantation at a single heart centre. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Use of a percutaneous temporary circulatory support device as a bridge to decision during acute decompensation of advanced heart failure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Hemodynamic Support (Impella) in Patients with Advanced Heart Failure and/or Cardiogenic Shock Not Eligible to PROTECT II Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiogenic shock secondary to severe acute ischemic mitral regurgitation managed with an Impella 2.5 percutaneous left ventricular assist device. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Initial experience with miniature axial flow ventricular assist devices for postcardiotomy heart failure. [2004]