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

June 30, 2026 updated by: Taipei Veterans General Hospital, Taiwan

Pulsed-Field Ablation for Persistent Atrial Fibrillation: Impact of Atrial Remodeling After Substrate Modification

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale Atrial fibrillation (AF) is associated with progressive electrical and structural remodeling of the left atrium. Electrical remodeling typically reverses within a week after restoration of sinus rhythm, whereas structural remodeling takes longer - generally 2 to 4 months - and successful ablation has been shown to improve left atrial transport function. Pre-procedural assessment with echocardiographic left atrial strain and delayed-enhancement MRI may help predict the extent of reverse remodeling after ablation.

Pulsed-field ablation (PFA) is a non-thermal ablation technology that uses pulsed electric fields to create focal lesions selectively targeting cardiomyocytes, while largely sparing surrounding structures such as the esophagus, phrenic nerve, and blood vessels. Compared with radiofrequency ablation (RFA), PFA can create larger and deeper lesions with fewer applications, with a potentially reduced risk of collateral injury. Beyond pulmonary vein isolation (PVI), PFA has also been applied to other atrial substrates, including the posterior wall and mitral line.

A recent study suggested that mean pulmonary arterial pressure did not worsen in patients with pre-existing pulmonary hypertension undergoing repeat PFA for recurrent AF. However, the impact of PFA on atrial remodeling in patients with persistent AF undergoing extensive substrate modification remains unknown. This study aims to characterize changes in atrial function and structural remodeling 3 to 12 months after PFA for PVI and extensive substrate modification, and to explore its relationship with procedural outcomes.

Study Design This is a prospective, single-center, single-arm observational clinical investigation conducted at Taipei Veterans General Hospital. Thirty patients with persistent AF will undergo the index ablation procedure using the FARAWAVE Catheter, FARADRIVE Catheter, and FARASTAR System (Boston Scientific). Enrollment will cease once approximately 30 subjects have been accrued. An interim endpoint analysis will be performed once all subjects have completed their 6-month follow-up. All participants will be followed for up to 12 months.

Procedure Pre-procedural care will follow the standard institutional protocol for AF ablation cases, with AF classification (paroxysmal vs. non-paroxysmal) defined according to the 2024 HRS consensus on catheter ablation of AF. Pre-procedural evaluation includes transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), cardiac CT and MRI, and 14-day Holter monitoring.

The ablation procedure is performed under deep sedation or general anesthesia, with PFA targeting pulmonary vein isolation and posterior wall isolation. Additional substrate modification may be performed using PFA at the physician's discretion. Conventional invasive hemodynamic assessment of left atrial function - including mean pulmonary artery pressure (mPAP), pulmonary arterial wedge pressure, cardiac output, vascular resistance, and right atrial pressure - will be performed before and after PFA during the procedure.

Post-procedural assessments include 12-lead ECG and in-hospital Holter monitoring within 3 days following PFA. At 3 to 12 months after the procedure, participants will undergo repeat echocardiography, cardiac CT and MRI, ECG, and 14-day Holter monitoring. Invasive hemodynamic assessment will be repeated approximately 3 months after the procedure.

Endpoints The primary endpoint is left atrial structural remodeling, including changes in LA size, atrial strain, extent of atrial fibrosis, and other atrial hemodynamic functions. The secondary endpoint is AF-free survival within 3 to 12 months following PFA. The main scientific question is to elucidate atrial remodeling following non-thermal ablation with PFA and its relationship to ablation outcomes.

Safety Monitoring All adverse events (AEs) and serious adverse events (SAEs) will be captured and classified by the investigator according to relatedness (procedure-related, device-related, cardiovascular-related, arrhythmia-related, heart failure-related), seriousness, timing (pre-procedure, during ablation, post-ablation), and diagnosis. Pre-specified serious adverse events of interest include cardiac tamponade or perforation, death, esophageal perforating complications, gastric motility / pyloric spasm disorders, heart block, myocardial infarction, hospitalization due to cardiovascular or pulmonary PFA system- or procedure-related events, pericarditis, peripheral or organ thromboembolism, pulmonary vein stenosis, severe hemolysis with subsequent renal failure or significant anemia, stroke, transient ischemic attack, unresolved phrenic nerve palsy or paresis, and vascular access complications.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Fa-Po Chung, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • FARAWAVE Catheter
  • FARADRIVE Catheter
  • FARASTAR System
  • FARAPULSE PFA System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Atrial Anteroposterior Diameter
Time Frame: Baseline, 3 months, 6 months, and 12 months post-procedure
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
Time Frame: Baseline, 3 months, 6 months, and 12 months post-procedure
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
Time Frame: Baseline, 3 months, 6 months, and 12 months post-procedure
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
Time Frame: Baseline, 3 months, 6 months, and 12 months post-procedure
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
Time Frame: Baseline, 3 months, 6 months, and 12 months post-procedure
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
Time Frame: Baseline and 3 to 12 months post-procedure
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)
Time Frame: Pre-procedure, immediately post-procedure, and 3 months post-procedure
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)
Time Frame: Pre-procedure, immediately post-procedure, and 3 months post-procedure
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
Time Frame: Pre-procedure, immediately post-procedure, and 3 months post-procedure
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
Time Frame: Pre-procedure, immediately post-procedure, and 3 months post-procedure
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
Time Frame: Pre-procedure, immediately post-procedure, and 3 months post-procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial Fibrillation-Free Survival
Time Frame: 3 to 12 months post-procedure
Proportion of subjects free from any documented atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds following a 90-day blanking period after the index pulsed-field ablation procedure. Recurrence is assessed by 12-lead ECG and 14-day Holter monitoring performed between 3 and 12 months post-procedure.
3 to 12 months post-procedure
Correlation Between Atrial Remodeling and Ablation Outcome
Time Frame: 3 to 12 months post-procedure
Correlation between post-procedural atrial structural remodeling parameters (left atrial size, atrial strain, extent of atrial fibrosis on delayed-enhancement cardiac MRI, and invasively measured atrial hemodynamic function) and atrial fibrillation-free survival following pulsed-field ablation. Each parameter's association with recurrence is expressed as a correlation coefficient. This analysis aims to identify imaging- and hemodynamic-based predictors of ablation success and to characterize the relationship between reverse atrial remodeling and clinical outcome.
3 to 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-03-008C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers. All study data analysis will be conducted within Taipei Veterans General Hospital, and no external data transfers are planned. Participant data will be anonymized and stored on a secure institutional server accessible only to authorized study personnel.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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