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Destination Therapy Post Approval Study

Study acronym: DT PAS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 22, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. 5 versions Re-verified since Apr 19, 2024, no change to tracked fieldsv36-v40
  2. Primary completion date: Apr 2023 to Apr 2026v35
  3. 4 versions Re-verified since Dec 7, 2021, no change to tracked fieldsv31-v34
  4. Eligibility criteria expanded, about 23 wordsv30
  5. 2 versions Re-verified since May 24, 2021, no change to tracked fieldsv28-v29
Show 26 earlier versionsHide 26 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 50 to 47
    v27
  2. Primary completion date: Nov 2025 to Apr 2023
    • Study completion date: Nov 2025 to Apr 2026
    • Site details revised at 4 of 50 sites
    v26
  3. Study sites: 49 to 50v25
  4. Site details revised at 2 of 49 sitesv24
  5. Site contacts updated at 1 of 49 sitesv23
  6. Study sites: 48 to 49v22
  7. Site details revised at 2 of 48 sitesv21
  8. Site details revised at 3 of 48 sitesv20
  9. Site details revised at 10 of 48 sitesv19
  10. Study sites: 47 to 48v18
  11. Study sites: 46 to 47v17
  12. Study sites: 42 to 46v16
  13. Site contacts updated at 1 of 42 sitesv15
  14. Site contacts updated at 3 of 42 sitesv14
  15. Study sites: 41 to 42v13
  16. Study sites: 39 to 41v12
  17. Study sites: 38 to 39v11
  18. Study sites: 17 to 38v10
  19. Study sites: 12 to 17v9
  20. Study sites: 7 to 12v8
  21. Study sites: 6 to 7v7
  22. Site details revised at 1 of 6 sitesv6
  23. Study sites: 5 to 6v5
  24. Study sites: 4 to 5v4
  25. Study sites: 1 to 4v3
  26. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 22, 2018 to Oct 31, 2018
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.
Trial Details
NCT Number NCT03681210
Lead Sponsor Medtronic Cardiac Rhythm and Heart Failure
Conditions
(from sponsor)		 Chronic Heart Failure
Related terms Cardiovascular Diseases, Heart Diseases, Heart Failure
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov