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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 from date of enrollment to 28 days or discharge from hospital & 90 days post-implant
Awards & highlights
BTR EFS Trial Summary
This trial is testing a new heart pump to see if it is safe and effective in helping people with heart problems 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.Check my eligibility
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.See study design
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.
BTR EFS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of enrollment to 28 days or discharge from hospital & 90 days post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment to 28 days or discharge from hospital & 90 days post-implant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility: successful hemodynamic support
Safety: Major Device-Related Adverse Events
Secondary outcome measures
All-cause mortality
Assessment of quality of life over baseline
Device malfunction
+4 moreBTR EFS Trial Design
1Treatment groups
Experimental Treatment
Group I: Subjects receiving the Impella BTRExperimental Treatment1 Intervention
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Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
34,545 Total Patients Enrolled
8 Trials studying Heart Failure
1,996 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the overall number of participants involved in this research initiative?
"Affirmative. Per the clinicaltrials.gov data, this medical study is currently enrolling patients; it was first published on April 20th 2022 and last modified on May 23rd 2022. 10 individuals must be recruited from 1 centre for participation in the trial."
Answered by AI
Are enrollees being accepted into this clinical experiment currently?
"Affirmative. According to information on clinicaltrials.gov, this investigation is still recruiting patients - with the original post going up on April 20th 2022 and the last edit being made on May 23rd 2022. The study is looking for 10 individuals from a single medical centre."
Answered by AI
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