Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Study acronym: PreVail-PH2
StatusEnrolling by Invitation
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 2026 → Jun 2027
See other at-risk trials from Gradient Denervation Technologies

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Jun 2027
    • Study completion pushed from Jul 1, 2028 to Jun 1, 2030
    • Eligibility criteria expanded, about 15 words
  2. Trial status: Recruiting to Enrolling by Invitation
    • Primary completion date: Jun 2026 to Dec 2026
    • Eligibility criteria revised
    • Site details revised at 8 of 8 sites
    v14
  3. Enrollment target: 30 to 50
    • Primary completion date: Dec 31, 2025 to Jun 2026
    v13
  4. Primary completion date: Sep 1, 2025 to Dec 31, 2025v12
  5. Study sites: 6 to 8v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jul 1, 2025 to Sep 1, 2025
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 1
    v10
  2. Study sites: 5 to 6v9
  3. Study sites: 4 to 5v8
  4. Primary endpoint revised
    • Secondary endpoints: 1 to 2
    v7
  5. Study sites: 3 to 4
    • Primary completion date: Feb 1, 2025 to Jul 1, 2025
    • Study completion date: Feb 1, 2028 to Jul 1, 2028
    • Eligibility criteria shortened, about 4 words
    v6
  6. Study sites: 2 to 3v5
  7. Study sites: 1 to 2v4
  8. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 2024 to Feb 1, 2025
    • Study completion date: Jun 2027 to Feb 1, 2028
    • Start date changed from estimate of Nov 2023 to Feb 20, 2024
  9. Secondary endpoints: 3 to 1v2
  1. Study First Submitted
  • 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 early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Trial Details
NCT Number NCT06052072
Lead Sponsor Gradient Denervation Technologies
Conditions
(from sponsor)		 Group 2 Pulmonary Hypertension, Heart Failure
Related terms Heart Failure
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov