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Impella ECP Early Feasibility Study

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words
    • Study description revised
  2. 2 versions Re-verified since Jan 5, 2026, no change to tracked fieldsv26-v27
  3. Primary and study completion dates: Oct 31, 2025 to Oct 31, 2026v25
  4. 2 versions Re-verified since Jul 7, 2025, no change to tracked fieldsv23-v24
  5. Study sites: 4 to 5v22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites revised (4)v21
  2. Primary and study completion dates: Oct 31, 2024 to Oct 31, 2025v20
  3. Primary completion date: Sep 30, 2024 to Oct 31, 2024v19
  4. Study description expanded, about 2 wordsv18
  5. Primary completion date: Sep 30, 2023 to Sep 30, 2024
    • Study completion date: Dec 31, 2023 to Oct 31, 2024
    v17
  6. Primary completion date: Mar 30, 2023 to Sep 30, 2023v16
  7. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Feb 28, 2023 to Mar 30, 2023
    • Study completion date: Mar 31, 2023 to Dec 31, 2023
    • Site details revised at 4 of 4 sites
    v15
  8. Site details revised at 2 of 4 sitesv14
  9. Eligibility criteria expanded, about 61 wordsv13
  10. Enrollment target: 50 to 100v12 Show 4 more changesShow less
    • Primary completion date: Feb 28, 2022 to Feb 28, 2023
    • Study completion date: Mar 31, 2022 to Mar 31, 2023
    • Site details revised at 3 of 4 sites
    • Eligibility criteria expanded, about 3 words
  11. Re-verified, no change to tracked fieldsv11
  12. Primary completion date: Oct 31, 2021 to Feb 28, 2022
    • Study completion date: Oct 31, 2021 to Mar 31, 2022
    v10
  13. Enrollment target: 20 to 50
    • Study sites: 3 to 4
    v9
  14. Primary completion date: Apr 30, 2021 to Oct 31, 2021v8
  15. Enrollment target: 5 to 20
    • Eligibility criteria expanded, about 4 words
    v7
  16. Re-verified, no change to tracked fieldsv6
  17. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v5
  18. Re-verified, no change to tracked fieldsv4
  19. Study sites: 1 to 3
    • Start date: Oct 1, 2020 to Oct 9, 2020
    v3
  20. Study sites: 0 to 1
    • Eligibility criteria shortened, about 7 words
    v2
  1. 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
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
Trial Details
NCT Number NCT04477603
Lead Sponsor Abiomed Inc.
Conditions
(from sponsor)		 High-risk Percutaneous Coronary Intervention
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov