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

NCT07675395 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-02

No results posted yet for this study

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.

Conditions

  • Persistent Atrial Fibrillation
  • Atrial Fibrillation (AF)
  • Atrial Remodeling
  • Pulsed Field Ablation

Interventions

DEVICE

Pulsed-Field Ablation with FARAWAVE Catheter System

Pulsed-field ablation is performed using the FARAWAVE / FARADRIVE Catheter and FARASTAR System (Boston Scientific) under deep sedation or general anesthesia. PFA is delivered to achieve pulmonary vein isolation and posterior wall isolation, with additional substrate modification at the operator's discretion. Invasive hemodynamic assessment is performed pre- and post-PFA during the index procedure and repeated at approximately 3 months.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675395 on ClinicalTrials.gov