Pulsed-Field Ablation for Persistent Atrial Fibrillation: Impact of Atrial Remodeling After Substrate Modification
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Left Atrial Anteroposterior Diameter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Pulsed-Field Ablation with FARAWAVE Catheter System (Device)
结局指标
主要结局
Change in Left Atrial Anteroposterior Diameter
时间窗: Baseline, 3 months, 6 months, and 12 months post-procedure
Change from baseline in left atrial anteroposterior (AP) diameter measured by transthoracic echocardiography.
Change in Left Atrial Volume Index
时间窗: Baseline, 3 months, 6 months, and 12 months post-procedure
Change from baseline in left atrial volume index measured by transthoracic echocardiography.
Change in Left Atrial Reservoir Strain
时间窗: 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.
Change in Left Atrial Conduit Strain
时间窗: 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.
Change in Left Atrial Contractile Strain
时间窗: 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.
Change in Extent of Left Atrial Fibrosis
时间窗: 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.
Change in Mean Pulmonary Artery Pressure (mPAP)
时间窗: 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.
Change in Pulmonary Arterial Wedge Pressure (PAWP)
时间窗: 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.
Change in Cardiac Output
时间窗: 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.
Change in Pulmonary Vascular Resistance
时间窗: 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.
Change in Right Atrial Pressure
时间窗: 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.
次要结局
- Atrial Fibrillation-Free Survival(3 to 12 months post-procedure)
- Association Between Atrial Remodeling and Ablation Outcome(3 to 12 months post-procedure)
- Correlation Between Atrial Remodeling and Ablation Outcome(3 to 12 months post-procedure)