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NCT05291884 · ClinicalTrials.gov registry record · NA
Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study
A NA study of Heart Failure and Acute Decompensated Heart Failure, sponsored by Abiomed.
- Active
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 6
- Study locations
NCT05291884: Active NA study of Heart Failure and Acute Decompensated Heart Failure, sponsored by Abiomed.
NCT05291884 is a NA study of Heart Failure and Acute Decompensated Heart Failure that is active but no longer recruiting, run by Abiomed. The registered enrollment target is 10 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05291884, a NA study of Heart Failure and Acute Decompensated Heart Failure, is active but no longer recruiting, sponsored by Abiomed.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next therapy.
Primary Outcome
The ability of the pump to provide clinically adequate support for the duration of the implant up to 28 days. Clinically adequate support is defined as operating without device malfunctions or failures that result in device removal, replacement or use of an additional MCS device.
Conditions Studied
Interventions
- DEVICE Impella BTR
Study Locations (6)
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
Georgia
- Emory University Hospital - Atlanta
Illinois
- Northwestern University - Evanston
New Jersey
- Hackensack University Medical Center - Hackensack
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2028-03 |
| Phase | NA |
What the registry record for NCT05291884 still lists
NCT05291884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Impella BTR is the first listed.
NCT05291884 lists 6 locations in 5 states (Massachusetts, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT05291884 about?
NCT05291884 is a clinical study titled "Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study". This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next thera...
What is the current status of trial NCT05291884?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2022-04-20. Estimated completion is 2028-03.
What conditions does trial NCT05291884 study?
This clinical trial studies the following conditions: Heart Failure, Acute Decompensated Heart Failure.
What interventions are being tested in trial NCT05291884?
The interventions under investigation include: Impella BTR (DEVICE).
Who is sponsoring clinical trial NCT05291884?
This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05291884 being conducted?
This trial has 6 study locations across Georgia, Illinois, Massachusetts, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05291884's enrollment target sits among peer trials
10 383rd of 397 higher than 7 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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