What side effects are associated with this type of intervention?

Mechanical circulatory support devices, such as the Impella BTR™, which assist the left ventricle in pumping blood, can have several side effects. These may include bleeding, infection, thrombosis (blood clots), hemolysis (destruction of red blood cells), and device malfunction. Additionally, patients may experience vascular complications due to the insertion of the device. Other common treatments for heart failure, such as beta blockers and ACE inhibitors, can cause side effects like hypotension (low blood pressure), dizziness, fatigue, and renal dysfunction.

What prior FDA approvals exist?

The FDA has approved several mechanical circulatory support devices for the treatment of heart failure, particularly for patients requiring left-ventricular hemodynamic support. Notable among these is the Impella series, including the Impella 2.5, Impella CP, and Impella 5.0, which are percutaneous heart pumps designed to assist the left ventricle in pumping blood. These devices are used in cases of cardiogenic shock and high-risk percutaneous coronary interventions. Additionally, the FDA has approved other treatments for heart failure, such as left ventricular assist devices (LVADs) like the HeartMate 3, which provide long-term support for patients awaiting heart transplants or those who are not candidates for transplantation.

What other types of research exist?

Promising alternatives to the Impella BTR™ for heart failure patients include the following: 1) Left Ventricular Assist Devices (LVADs) such as the HeartMate 3™, which offers improved hemocompatibility and reduced thrombosis risk. 2) The use of novel pharmacological agents like vericiguat, a soluble guanylate cyclase stimulator, which has shown potential benefits in heart failure management. 3) Emerging gene and cell therapies aimed at regenerating cardiac tissue and improving heart function. These alternatives are under continuous research and development, with some already showing promising results in clinical trials.

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Ventricular Assist Device

Impella BTR for Heart Failure (BTR EFS Trial)

N/A

Recruiting

Led By David D'Alessandro, MD

Research Sponsored by Abiomed Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 90 days post-implant

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of using the Impella BTR™ may include complications at the site where it's inserted into the body such as infection or bleeding; reactions related to heparin use if allergic; issues due to contrast media used during procedures; and general risks associated with left-ventricular support devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 90 days post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 90 days post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 90 days post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility: successful hemodynamic support

Safety: Major Device-Related Adverse Events

Secondary study objectives

Assessment of quality of life over baseline

Device malfunction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects receiving the Impella BTRExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include pharmacological agents like beta blockers, ACE inhibitors, ARBs, and aldosterone antagonists, which help reduce the heart's workload, lower blood pressure, and prevent fluid retention. Mechanical circulatory support devices, such as the Impella BTR™, assist the left ventricle in pumping blood, providing immediate hemodynamic support. This is vital for heart failure patients as it helps maintain adequate circulation and organ perfusion, stabilizing the patient and allowing time for further therapeutic decisions.

Sustained Use of the Impella 5.0 Heart Pump Enables Bridge to Clinical Decisions in 34 Patients.Current indication and practical management of percutaneous left ventricular assist device support therapy in Japan.Surgical therapy for dilated cardiomyopathy.