Not Yet RecruitingNot Applicable

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

Taiwan30 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Left Atrial Anteroposterior Diameter

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

Change in Left Atrial Volume Index

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

Change in Left Atrial Reservoir Strain

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

Change in Left Atrial Conduit Strain

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

Change in Left Atrial Contractile Strain

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

Change in Extent of Left Atrial Fibrosis

Timeframe: Baseline and 3 to 12 months post-procedure

Change in Mean Pulmonary Artery Pressure (mPAP)

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

Trial details

NCT IDNCT07675395

SponsorTaipei Veterans General Hospital, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Fa-Po Dr. Chung, MD, PhD

886-2-28712121 marxtaiji@gmail.com

View on ClinicalTrials.gov More Persistent Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Left Atrial Anteroposterior Diameter

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

Change in Left Atrial Volume Index

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

Change in Left Atrial Reservoir Strain

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

Change in Left Atrial Conduit Strain

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

Change in Left Atrial Contractile Strain

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

Change in Extent of Left Atrial Fibrosis

Timeframe: Baseline and 3 to 12 months post-procedure

Change in Mean Pulmonary Artery Pressure (mPAP)

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