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Clinical Trial

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

NCT: NCT07675395 · NOT_YET_RECRUITING

NCT IDNCT07675395
StatusNOT_YET_RECRUITING
Start Date2026-07-01
Completion2028-12-31
SponsorTaipei Veterans General Hospital, Taiwan (OTHER_GOV)
First posted
Last updated

Brief Summary

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.

Frequently Asked Questions

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

Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF) is a clinical trial registered under NCT07675395. Current status: NOT_YET_RECRUITING.

What is the status of NCT07675395?

The current status of NCT07675395 (Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)) is: NOT_YET_RECRUITING.

When did Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF) start?

Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF) started on 2026-07-01.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.