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AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

Study acronym: ICE-AFIB
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Jun 2024 to Jun 27, 2024
    • Study completion date: Dec 2026 to Jun 2026
    v14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 18 to 15
    • Primary completion date: Jul 2024 to Jun 2024
    v13
  3. Site details revised at 6 of 18 sitesv12
  4. Study sites: 17 to 18v11
  5. Primary completion date: Jul 2022 to Jul 2024
    • Study sites: 15 to 17
    • Study completion date: Jul 2024 to Dec 2026
    • Eligibility criteria revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Primary completion date: Jul 2020 to Jul 2022v8 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study completion date: Jul 2023 to Jul 2024
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints revised (7)
  3. Study sites: 13 to 15v7
  4. Study sites: 11 to 13v6
  5. Study sites: 8 to 11v5
  6. Study sites: 4 to 8v4
  7. Study sites: 1 to 4v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2018 to Jan 30, 2019
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AtriCure, Inc.
9 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Atrial Fibrillation
1,182 trials monitored
See 50 trials at risk
The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.
Trial Details
NCT Number NCT03732794
Lead Sponsor AtriCure, Inc.
Conditions
(from sponsor)		 Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov