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Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study
NCT05291884 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05291884
The ClinicalTrials.gov registry entry for NCT05291884 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05291884 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05291884?
The interventions under investigation include: Impella BTR (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05291884?
This trial is sponsored by Abiomed, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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