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Tracking Results of Ablations to Combat AF Registry Generation 2

Study acronym: TRAC-AF
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion pushed from Jan 2030 to Jan 2040
    • Start date: Feb 2013 to Mar 11, 2024
    • Study sites: 28 to 29
    v9
  2. Enrollment target: 7400 to 10000v8 Show 4 more changesShow less
    • Study sites: 23 to 28
    • Interventions: AtriCure Hybrid Totally Thoracoscopic Ablation Procedures (Device), AtriCure LAA Exclusion Procedures (Device), Concomitant Open Heart… to AtriCure Hybrid Totally Thoracoscopic Ablation Procedures (Device), AtriCure LAA Exclusion Procedures (Device), Hybrid (Convergent)…
    • Eligibility criteria shortened, about 58 words
    • Study description expanded, about 36 words
  3. Enrollment target: 6400 to 7400
    • Study sites: 11 to 23
    v7
  4. Study sites: 2 to 11
    • Interventions: AtriCure LAA Exclusion Procedures (Device), Concomitant Open Heart Surgical Ablation Procedures (Device), Hybrid (Convergent) Ablation… to AtriCure Hybrid Totally Thoracoscopic Ablation Procedures (Device), AtriCure LAA Exclusion Procedures (Device), Concomitant Open Heart…
    v6
  5. Primary and study completion dates: Jan 2027 to Jan 2030v5 Show 6 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Enrollment target: 5000 to 6400
    • Interventions: AtriCure AtriClip® LAA Exclusion System (Device), AtriCure Isolator® Synergy™ Surgical Ablation System (Device) to AtriCure LAA Exclusion Procedures (Device), Concomitant Open Heart Surgical Ablation Procedures (Device), Hybrid (Convergent) Ablation…
    • Eligibility criteria expanded, about 68 words
    • Study description expanded, about 47 words
    • Study title expanded, about 2 words
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Primary endpoints revised (2)v3
  3. Primary endpoints revised (2)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.
Trial Details
NCT Number NCT05111015
Lead Sponsor AtriCure, Inc.
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov