Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04153292 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

The ENCIRCLE Trial

Study acronym: ENCIRCLE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Feb 28, 2027 → Oct 10, 2027
See other at-risk trials from Edwards Lifesciences

Record History

  1. Primary completion pushed from Feb 28, 2027 to Oct 10, 2027 Enrollment closed, study ongoing · Trial sites reduced: 68 → 54 locations · Final enrollment: 786 participants (planned 900) · 4 more Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites reduced: 68 → 54 locations
    • Final enrollment: 786 participants (planned 900)
    • Completion pushed from Feb 28, 2031 to Oct 10, 2031
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv36
  3. Primary completion date: Feb 2027 to Feb 28, 2027 Completion date: Feb 2031 to Feb 28, 2031 · Site details revised at 35 of 68 sitesv35 Show 2 more changesShow less
    • Completion date: Feb 2031 to Feb 28, 2031
    • Site details revised at 35 of 68 sites
  4. Site details revised at 5 of 68 sitesv34
  5. Study sites revised (68)v33 See this version in full on ClinicalTrials.gov ↗
Show 31 earlier versionsHide 31 earlier versions
  1. Site details revised at 1 of 68 sitesv32
  2. Site details revised at 2 of 68 sitesv31
  3. Site details revised at 1 of 68 sitesv30
  4. Site details revised at 1 of 68 sitesv29
  5. Enrollment target: 500 to 900 Primary completion date: Feb 2024 to Feb 2027 · Completion date: Feb 2028 to Feb 2031v28 Show 2 more changesShow less
    • Primary completion date: Feb 2024 to Feb 2027
    • Completion date: Feb 2028 to Feb 2031
  6. Study sites: 67 to 68v27
  7. Site details revised at 7 of 67 sitesv26
  8. Site details revised at 5 of 67 sitesv25
  9. Site details revised at 1 of 67 sitesv24
  10. Study sites revised (67)v23 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 66 to 67v22
  12. Study sites: 64 to 66v21
  13. Study sites: 63 to 64v20
  14. Study sites: 61 to 63v19
  15. Study sites: 59 to 61v18
  16. Study sites: 57 to 59v17
  17. Study sites: 55 to 57v16
  18. Study sites: 53 to 55v15
  19. Study sites: 52 to 53v14
  20. Study sites: 51 to 52v13
  21. Study sites: 49 to 51v12
  22. Enrollment target: 400 to 500 Study sites: 45 to 49 · Eligibility criteria revised · Study arms: 2 to 3v11 Show 3 more changesShow less
    • Study sites: 45 to 49
    • Eligibility criteria revised
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 43 to 45v10
  24. Study sites: 37 to 43v9
  25. Study sites: 27 to 37v8
  26. Study sites: 22 to 27v7
  27. Study sites: 15 to 22v6
  28. Study sites: 13 to 15v5
  29. Study sites: 5 to 13v4
  30. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Recruiting · Primary completion date: Feb 2024 · Completion date: Feb 2028 · 6 morev3 Show 9 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Feb 2024
    • Completion date: Feb 2028
    • Start date: Nov 12, 2020
    • Eligibility criteria expanded, about 81 words
    • Secondary endpoints expanded, about 28 words
    • Study description expanded, about 7 words
    • Study sites expanded, about 13 words
    • Study title shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  31. Lead sponsor: Edwards Lifesciences to [Redacted] Trial status: Not Yet Recruiting to Withheld · Primary completion date: Mar 2023 to not stated · Completion date: Mar 2027 to not stated · 2 morev2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Withheld
    • Primary completion date: Mar 2023 to not stated
    • Completion date: Mar 2027 to not stated
    • Start date: Feb 2020 to not stated
    • Study title expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  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.
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Trial Details
NCT Number NCT04153292
Lead Sponsor Edwards Lifesciences
Conditions Mitral Regurgitation, Mitral Valve Insufficiency
Enrollment 786 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov