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The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

Study acronym: PIVATAL
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion pushed from Apr 30, 2026 to Apr 30, 2027v14
  2. Primary completion date: Dec 31, 2025 to Apr 30, 2026
    • Study completion date: Jun 30, 2026 to Jun 30, 2027
    v13
  3. Study sites: 1 to 19v12
  4. Start date: Jun 15, 2022 to May 27, 2022v11
  5. Start date: May 27, 2022 to Jun 15, 2022v10
Show 8 earlier versionsHide 8 earlier versions
  1. 2 versions Re-verified since Feb 19, 2024, no change to tracked fieldsv8-v9
  2. Phase: Not applicable to Phase 4v7
  3. Eligibility criteria expanded, about 28 wordsv6
  4. Primary completion date: Dec 21, 2026 to Dec 31, 2025
    • Study completion date: Dec 31, 2026 to Jun 30, 2026
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2022 to May 27, 2022
    v4
  6. Primary completion date: Mar 28, 2026 to Dec 21, 2026
    • Start date: Mar 28, 2022 to Jun 1, 2022
    • Study completion date: Mar 28, 2026 to Dec 31, 2026
    v3
  7. Primary and study completion dates: Feb 28, 2026 to Mar 28, 2026
    • Start date: Feb 28, 2022 to Mar 28, 2022
    • Eligibility criteria shortened, about 41 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
Trial Details
NCT Number NCT05034432
Lead Sponsor University of Rochester
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Arrythmia, Cardiomyopathies
Related terms Arrhythmias, Cardiac, Cardiomyopathies
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov