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

NCT07675395 | Not Yet Recruiting

• 1 other identifier: 2026-03-008C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pulsed Field Ablation; Persistent Atrial Fibrillation; Atrial Fibrillation; Atrial Remodeling; Substrate Modification; Atrial Fibrosis; Cardiac MRI; Posterior Wall Isolation

Outcome Measures

Primary Outcomes (11)

• Change in Left Atrial Anteroposterior Diameter

  Change from baseline in left atrial anteroposterior (AP) diameter measured by transthoracic echocardiography.

  Baseline, 3 months, 6 months, and 12 months post-procedure

• Change in Left Atrial Volume Index

  Change from baseline in left atrial volume index measured by transthoracic echocardiography.

  Baseline, 3 months, 6 months, and 12 months post-procedure

• Change in Left Atrial Reservoir Strain

  Change from baseline in left atrial reservoir strain assessed by transthoracic echocardiography with speckle-tracking analysis.

  Baseline, 3 months, 6 months, and 12 months post-procedure

• Change in Left Atrial Conduit Strain

  Change from baseline in left atrial conduit strain assessed by transthoracic echocardiography with speckle-tracking analysis.

  Baseline, 3 months, 6 months, and 12 months post-procedure

• Change in Left Atrial Contractile Strain

  Change from baseline in left atrial contractile strain assessed by transthoracic echocardiography with speckle-tracking analysis.

  Baseline, 3 months, 6 months, and 12 months post-procedure

• Change in Extent of Left Atrial Fibrosis

  Change from baseline in the extent of left atrial fibrosis assessed by delayed-enhancement cardiac magnetic resonance imaging (MRI), expressed as the percentage of fibrotic left atrial wall relative to total left atrial wall area.

  Baseline and 3 to 12 months post-procedure

• Change in Mean Pulmonary Artery Pressure (mPAP)

  Change from baseline in mean pulmonary artery pressure. Invasively measured during cardiac catheterization, performed immediately before and after PFA during the index procedure, and repeated approximately 3 months post-procedure.

  Pre-procedure, immediately post-procedure, and 3 months post-procedure

• Change in Pulmonary Arterial Wedge Pressure (PAWP)

  Change from baseline in pulmonary arterial wedge pressure. Invasively measured during cardiac catheterization, performed immediately before and after PFA during the index procedure, and repeated approximately 3 months post-procedure.

  Pre-procedure, immediately post-procedure, and 3 months post-procedure

• Change in Cardiac Output

  Change from baseline in cardiac output. Invasively measured during cardiac catheterization, performed immediately before and after PFA during the index procedure, and repeated approximately 3 months post-procedure.

  Pre-procedure, immediately post-procedure, and 3 months post-procedure

• Change in Pulmonary Vascular Resistance

  Change from baseline in pulmonary vascular resistance. Invasively measured during cardiac catheterization, performed immediately before and after PFA during the index procedure, and repeated approximately 3 months post-procedure.

  Pre-procedure, immediately post-procedure, and 3 months post-procedure

• Change in Right Atrial Pressure

  Change from baseline in right atrial pressure. Invasively measured during cardiac catheterization, performed immediately before and after PFA during the index procedure, and repeated approximately 3 months post-procedure.

  Pre-procedure, immediately post-procedure, and 3 months post-procedure

Secondary Outcomes (2)

• Atrial Fibrillation-Free Survival

  3 to 12 months post-procedure

• Correlation Between Atrial Remodeling and Ablation Outcome

  3 to 12 months post-procedure

Study Arms (1)

Pulsed-Field Ablation Group

EXPERIMENTAL

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.

Device: Pulsed-Field Ablation with FARAWAVE Catheter System

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.

Also known as: FARAWAVE Catheter, FARADRIVE Catheter, FARASTAR System, FARAPULSE PFA System

Pulsed-Field Ablation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of persistent atrial fibrillation
• Left atrial anteroposterior (AP) diameter greater than 4 cm and less than 6 cm
• Anti-arrhythmic medications (except amiodarone) discontinued for at least 5 half-lives before the procedure
• No use of beta-blockers or diuretics before or after the ablation procedure
• Willing and able to provide written informed consent

You may not qualify if:

• Paroxysmal atrial fibrillation
• Previous left atrial surgery or catheter ablation procedure, including left atrial appendage closure
• Atrial fibrillation due to reversible causes, such as thyroid disorders, acute alcohol intoxication, or other major surgeries within the 90 days preceding the procedure
• Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass grafting within 90 days of the procedure
• Known presence of cardiac thrombus
• Stroke or transient ischemic attack within the last 90 days
• Any other anatomical or comorbid condition that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial, comply with follow-up requirements, or impact the scientific validity of the clinical trial results

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Remodeling

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Central Study Contacts

Fa-Po Dr. Chung, MD, PhD

CONTACT

886-2-28712121; marxtaiji@gmail.com

Dr. Chiang, PhD

CONTACT

886-2-28712121; qqsnoopy0223@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm study. All participants and investigators are aware of the treatment assignment, and no masking or blinding procedures are implemented.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single-arm, single-center, prospective observational cohort. All enrolled subjects with persistent atrial fibrillation will undergo the index ablation procedure using pulsed-field ablation (FARAWAVE / FARADRIVE Catheter and FARASTAR System) for pulmonary vein isolation and extensive substrate modification, and will be followed for 12 months. An interim analysis will be performed once all subjects complete their 6-month follow-up.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)