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Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

Study acronym: ASTRAL-4LV
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 5, 2024 (before its estimated June 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 152 to confirmed 92
    • Site details revised at 21 of 21 sites
    v6
  2. Primary completion date: Jul 2022 to Jun 2024
    • Study sites: 17 to 21
    • Study completion date: Dec 2025 to Dec 2027
    v5
  3. Study sites: 5 to 17v4
  4. Site details revised at 3 of 5 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Nov 2020 to Dec 3, 2020
    • Eligibility criteria expanded, about 10 words
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MicroPort CRM
6 trials monitored
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Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.
Trial Details
NCT Number NCT04463641
Lead Sponsor MicroPort CRM
Conditions
(from sponsor)		 Heart Failure, Cardiac Resynchronization Therapy
Related terms Heart Failure
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov