Multitarget Pulse Field Ablation Guided by Endocardial and Non-invasive Atrial Driver Mapping (PFA+ADM) Pilot Study. Development of an Ablation Strategy to Improve the Efficacy of Long Standing Atrial Fibrillation Ablation in Patients With High Comorbidity Burden or Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of Successful Pulmonary Vein Isolation and Freedom from Atrial Fibrillation or Reduction in Arrhythmia Burden
研究概览
简要总结
To assess the efficacy and safety of a percutaneous ablation strategy that targets multiple extrapulmonary structures as the Cox-Maze IV.
详细描述
Persistent and long-standing atrial fibrillation (PsAF and LSAF) remain significant clinical challenges, particularly in patients with heart failure or high comorbidity burden, where the arrhythmia is often more sustained, complex, and resistant to conventional ablation approaches. Despite advancements in ablation technology, pulmonary vein isolation (PVI) alone has shown limited success in this subgroup. Current guidelines acknowledge the need for additional ablation targets beyond the pulmonary veins (PVs), yet evidence remains scarce and optimal strategies undefined.
This single-arm, prospective pilot study investigates a novel ablation strategy that combines multi-target pulsed field ablation (PFA) with both endocardial intracavitary electrogram (EGM) mapping and non-invasive body surface mapping (BSM) to guide the identification and ablation of extra-PV atrial fibrillation drivers. This approach is designed to emulate the multilevel strategy of the surgical Cox-Maze IV, aiming for comprehensive arrhythmia substrate modification while minimizing procedural risk.
The PFA+ADM protocol leverages recent advances in:
- Pulsed Field Ablation (PFA): a non-thermal modality offering selective myocardial ablation with reduced risk to adjacent tissues (e.g., esophagus, phrenic nerve).
- Non-invasive Driver Mapping (ADM): Electrocardiographic imaging (ECGi) with torso vests capable of reconstructing 3D epicardial activation patterns and identifying high-frequency or rotational driver sites.
- Intracardiac Electrogram Analysis: High-resolution EGM signals captured during atrial fibrillation are analyzed to localize driver activity, complex fractionated atrial electrograms (CFAEs), or high dominant frequency regions.
Study Workflow
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and
- •Ability and willingness to follow the study protocol, including informed consent.
- •Symptomatic long-standing AF for at least one month, documented by ECG or dual-chamber device recordings.
- •History of failure, intolerance, or refusal of antiarrhythmic drug therapy.
- •New York Heart Association (NYHA) functional class II or III, or left ventricular dysfunction (LVEF ≤ 50%) or a CHA2DS2-VASc score of 4 or more.
- •Optimal medical treatment for heart failure for at least three months for patients with left ventricular dysfunction.
排除标准
- •Left atrial diameter >5.5 cm.
- •Previous left atrial ablation or surgery.
- •Lack of anticoagulation therapy for 3 weeks prior to the procedure.
- •Pulmonary vein stents or stenosis.
- •Pre-existing diaphragmatic paralysis.
- •Cardiac valve prosthesis or significant valve disease.
- •Recent cardiac surgery or interventions within the past 3 months.
- •Unstable angina, NYHA Class IV heart failure.
- •Pulmonary hypertension or rheumatic heart disease.
- •Blood clotting disorders.
- •Contraindications to chronic anticoagulation.
- •Active infection or hypertrophic cardiomyopathy.
- •Reversible causes of AF, such as hyperthyroidism or sleep apnea.
- •Stroke or TIA in the past 6 months.
- •History of thromboembolic events or evidence of intracardiac thrombus.
- •Women of childbearing age
- •Life expectancy less than 12 months.
- •Participation in another clinical trial.
- •Allergy to adhesives.
- •Inability to comply with study procedures.
- •Inability to provide personal consent.
- •NYHA Class IV heart failure.
- •Left ventricular ejection fraction ≤ 25%.
结局指标
主要结局
Incidence of Successful Pulmonary Vein Isolation and Freedom from Atrial Fibrillation or Reduction in Arrhythmia Burden
时间窗: 1 year
Success is defined as complete isolation of all pulmonary veins and either absence of atrial fibrillation recurrence or a significant reduction in arrhythmia burden over a 1-year follow-up period.
Incidence of Procedure-Related Complications, Including Mortality, Pulmonary Vein Stenosis, Nerve Injury, Stroke, and Major Bleeding Events [Safety]
时间窗: 6 months
The safety endpoint is defined as maintaining a complication rate of ≤5%, assessed by monitoring for acute and long-term complications such as mortality, pulmonary vein stenosis, nerve injury, stroke, bleeding, and other serious adverse events occurring within 30 days to 6 months post-procedure.
次要结局
- Percentage of patients in Per AF at the end of follow-up(1 year)
- Time to the first episode of atrial arrhythmia of more than 30 seconds(1 year)
- Percentage of patients with AF/AT recurrence(1 year)
- Percentage of patients with <50% of AF/AT burden(1 year)
- Left ventricular end-systolic volume at the end of follow-up(1 year)
- Left ventricular end-diastolic volume at the end of follow-up(1 year)
- Left ventricular ejection fraction (LVEF) at the end of follow-up(1 year)
- NYHA Functional Class at the end of follow-up(1 year)
- Adverse events of the procedures(1 year)
- Unplanned hospital admission for any reason(1 year)
- Procedure duration/fluoroscopy time(Measured on the day of the ablation procedure. No time frame.)
- Unplanned hospital admission for cardiovascular reasons(1 year)
- New onset heart failure(1 year)
- Worsening of functional class due to heart failure(1 year)