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Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Enrolling by invitation only
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site contact updated
  2. Secondary endpoints revised (2)v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 associated with both electrical and structural remodeling of the left atrium. While successful catheter ablation has been shown to reverse some aspects of atrial remodeling, the impact of pulsed-field ablation (PFA) - a non-thermal ablation technology that selectively targets cardiomyocytes while sparing surrounding structures - on atrial remodeling in patients with persistent AF undergoing extensive substrate modification remains unclear. This is a prospective, single-center, single-arm observational study conducted at Taipei Veterans General Hospital. The study will enroll 30 patients with persistent atrial fibrillation who undergo pulmonary vein isolation (PVI) and extensive substrate modification using the FARAWAVE / FARADRIVE Catheter and FARASTAR System. The primary objective is to evaluate left atrial structural remodeling following PFA, including changes in LA size, atrial strain, extent of atrial fibrosis, and atrial hemodynamic function. The secondary objective is to assess AF-free survival between 3 and 12 months after the procedure, and its relationship to atrial remodeling. All participants will be followed for 12 months, with an interim analysis conducted once all subjects complete their 6-month follow-up.
Trial Details
NCT Number NCT07675395
Lead Sponsor Taipei Veterans General Hospital, Taiwan
Collaborators: Boston Scientific Corporation
Conditions
(from sponsor)		 Persistent Atrial Fibrillation, Atrial Fibrillation (AF), Atrial Remodeling, Pulsed Field Ablation
Related terms Atrial Fibrillation, Atrial Remodeling
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov