NCT07675395Enrolling by invitation
Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)
Pulsed-Field Ablation for Persistent Atrial Fibrillation: Impact of Atrial Remodeling After Substrate Modification
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Diseases
- Atrial fibrillation
- NCT number
- NCT07675395
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jul 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrial surgery or catheter ablation procedure, including left atrial appendage closure
Other illness
- 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
Other
- Paroxysmal atrial fibrillation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.