Impella BTR for Heart Failure

Phase-Based Progress Estimates
Tufts Medical Center, Boston, MAHeart Failure+1 MoreImpella BTR - Device
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new heart pump to see if it is safe and effective in helping people with heart problems recover.

Eligible Conditions
  • Heart Failure
  • Acute Heart Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: From date of enrollment to 28 days or discharge from hospital & 90 days post-implant

Day 90
Assessment of quality of life over baseline
Day 28
Feasibility: successful hemodynamic support
Day 28
Device malfunction
Pump thrombus
Day 28
Length of hospital stay
Number of participants with Major Hemolysis
Safety: Major Device-Related Adverse Events
Day 90
All-cause mortality

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

1 Treatment Group

Subjects receiving the Impella BTR
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Impella BTR · No Placebo Group · N/A

Subjects receiving the Impella BTR
Experimental Group · 1 Intervention: Impella BTR · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of enrollment to 28 days or discharge from hospital & 90 days post-implant

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
37 Previous Clinical Trials
33,643 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
1,002 Total Patients Enrolled
Jane Wilcox, MD MScPrincipal InvestigatorNorthwestern University Hospital

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

What is the overall number of participants involved in this research initiative?

"Affirmative. Per the 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." - Anonymous Online Contributor

Unverified Answer

Are enrollees being accepted into this clinical experiment currently?

"Affirmative. According to information on, 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.