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Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study

Study acronym: ASCEND EV
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Oct 5, 2025 to Oct 27, 2025
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 35 to confirmed 19
    • Primary completion date: Jul 31, 2025 to Oct 5, 2025
    • Site details revised at 3 of 3 sites
    v6
  3. Site details revised at 1 of 3 sitesv5
  4. Site details revised at 1 of 3 sitesv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v3
  6. Enrollment target: 30 to 35
    • Start date: Feb 18, 2025 to Feb 25, 2025
    • Eligibility criteria expanded, about 83 words
    • Study description shortened, about 11 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of follow-up to inform the design of a subsequent pivotal clinical investigation. The objectives of the study are to: 1) preliminarily validate safety and effectiveness of the Atala™ lead as a permanent ICD lead when used with a compatible ICD pulse generator, 2) evaluate suitability of clinical study testing methods and 3) inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation.
Trial Details
NCT Number NCT06592001
Lead Sponsor AtaCor Medical, Inc.
Conditions
(from sponsor)		 Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Related terms Tachycardia, Ventricular, Ventricular Fibrillation
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov