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

Sponsor
Taipei Veterans General Hospital, Taiwan
Study ID
NCT07675395
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pulsed-Field Ablation with FARAWAVE Catheter System — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed-Field Ablation Group
    Subjects with persistent atrial fibrillation undergoing the index ablation procedure with pulsed-field ablation (PFA) for pulmonary vein isolation and posterior wall isolation, with additional substrate modification at the operator's discretion. The procedure is performed under deep sedation or general anesthesia using the FARAWAVE Catheter, FARADRIVE Catheter, and FARASTAR System. Invasive hemodynamic assessment (mean pulmonary artery pressure, pulmonary arterial wedge pressure, cardiac output, vascular resistance, right atrial pressure) is performed immediately before and after PFA during the procedure, and repeated approximately 3 months post-procedure. All subjects are followed for 12 months, with structural and functional reassessment by echocardiography, cardiac CT, cardiac MRI, and 14-day Holter monitoring at 3 to 12 months.

Primary Outcome Measure

Change in Left Atrial Anteroposterior Diameter [ Time Frame: Baseline, 3 months, 6 months, and 12 months post-procedure ]

Central Contacts

Related Studies