Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04823299 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation

Study acronym: AWARE-2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Not Yet Recruiting to Recruitingv9 Show 8 more changesShow less
    • Start date changed from estimate of Aug 2025 to Mar 23, 2026
    • Primary completion date: Sep 2028 to Mar 2029
    • Study completion date: Feb 2029 to Mar 2030
    • Interventions: Cryoballoon ablation (Procedure), Radiofrequency catheter ablation +EPS guided trigger and substrate ablation (Procedure) to PVI-ONLY, CONTROL ARM (Procedure), PVI-PLUS ARM, INTERVENTIONAL ARM (Procedure)
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 12 to 16
    • Study description shortened, about 76 words
    • Site details revised at 2 of 2 sites
  3. Primary completion date: Sep 2026 to Sep 2028v8 Show 5 more changesShow less
    • Start date: Jul 2024 to Aug 2025
    • Enrollment target: 390 to 556
    • Study completion date: Sep 2026 to Feb 2029
    • Collaborators revised (2)
    • Study title expanded, about 14 words
  4. Start date: Jan 2024 to Jul 2024v7
  5. Start date: Sep 2023 to Jan 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Mar 2023 to Sep 2023
    • Primary and study completion dates: Jul 2026 to Sep 2026
    v5
  2. Start date: Jul 2022 to Mar 2023v4
  3. Start date: Dec 2021 to Jul 2022
    • Primary and study completion dates: Dec 2026 to Jul 2026
    v3
  4. Start date: Jun 2021 to Dec 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Atrial fibrillation (AF) is a common heart rhythm disorder affecting over a million people in North America and is associated with serious complications including stroke, heart failure, reduced quality of life, and premature death. Catheter ablation has been shown to be more effective than medications for controlling symptoms and reducing the risk of these complications; however, recurrence of AF after ablation remains a significant challenge, often due to incomplete or ineffective initial procedures. This clinical trial aims to determine whether a novel, patient-tailored ablation strategy can improve outcomes compared to the current standard-of-care approach. Participants will be randomly assigned to undergo either standard pulmonary vein isolation or a more individualized ablation procedure that identifies and targets patient-specific sources of AF. All participants will undergo the ablation procedure, receive continuous heart rhythm monitoring, and be followed over time to assess recurrence and safety outcomes.
Trial Details
NCT Number NCT04823299
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Canadian Institutes of Health Research (CIHR), Abbott
Conditions
(from sponsor)		 Atrial Fibrillation, Catheter Ablation, Radiofrequency Catheter Ablation
Related terms Atrial Fibrillation
Enrollment 556 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov