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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
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
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects receiving the Impella BTRExperimental Treatment1 Intervention
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.
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.
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Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
33,009 Total Patients Enrolled
8 Trials studying Heart Failure
1,044 Patients Enrolled for Heart Failure
David D'Alessandro, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
1,019 Total Patients Enrolled
Jane Wilcox, MD MScPrincipal InvestigatorNorthwestern University Hospital
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Eligibility Criteria:
This trial includes the following eligibility 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.You have a lung condition that needs you to use oxygen at home.You have had COVID-19 symptoms or been in the hospital for COVID-19 in the past, unless you have fully recovered for at least 8 weeks.You have a problem with your aortic valve that is more than mild, and it shows signs of aortic sclerosis on a heart ultrasound.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 cannot tolerate medications that prevent blood clots or control bleeding.You have sickle cell anemia or thalassemia.You have been diagnosed with heart failure less than 90 days before the study starts.You have had surgery to replace or repair your aortic valve in the past.Your prealbumin levels are below 15 mg/dL or your albumin levels are below 3 g/dL.You have a blood clot in your heart.You had a type of heart attack called STEMI within the past 30 days.You recently had a severe heart problem and are currently using machines to help your heart or breathe.You had a cardiac arrest that wasn't witnessed, or you received CPR for at least 30 minutes before enrolling in the study, or you had a cardiac arrest that affected your mental or physical abilities.You have a history of bleeding problems, recent bleeding in your urinary or digestive system, or you refuse to receive a blood transfusion.You have had a heart transplant in the past.You have a heart condition that needs mechanical or inotropic support before getting the device implant.You had a stroke or bleeding in the brain within the last 90 days, or have a history of significant blockage in the carotid artery, or have permanent nerve damage due to brain-related issues.You are currently receiving dialysis treatment.You have severe heart failure before entering the study.You have sudden heart failure and meet one of the following conditions:You need assistance from a device called an intra-aortic balloon pump.You have a known condition affecting your aorta.You have a condition that makes it impossible to use an Impella® heart pump, like narrow or twisted blood vessels or a small axillary artery.You have certain heart conditions like restrictive or obstructive cardiomyopathy, constrictive pericarditis, or pericardial tamponade.Your heart is not pumping enough blood, and this is not because of low fluid levels in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects receiving the Impella BTR
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.
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