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Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study

Study acronym: BTR EFS
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Oct 2023 to Dec 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 6
    • Study completion date: Jan 2024 to Mar 2028
    v5
  3. Site details revised at 1 of 7 sitesv4
  4. Primary completion date: Oct 2022 to Oct 2023
    • Study sites: 1 to 7
    • Study completion date: Jan 2023 to Jan 2024
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2022 to Apr 20, 2022
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Abiomed Inc.
13 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT05291884
Lead Sponsor Abiomed Inc.
Conditions
(from sponsor)		 Heart Failure, Acute Decompensated Heart Failure
Related terms Heart Failure
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov