Optimal Ablation Strategies for Persistent Atrial Fibrillation With Heart Failure - Optimization of Intervention Strategies for Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- a composite of cardiovascular mortality, hospitalization or urgent visits
研究概览
简要总结
Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis. Catheter ablation has been shown to improve outcomes in this population, enhancing ablation success rates in these patients is critical for further reducing morbidity and mortality. We conducted this multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.
详细描述
Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis, with one-year all-cause mortality rates approaching 34% and substantially elevated risks of stroke and rehospitalization. Catheter ablation has been shown to improve outcomes in this population, as evidenced by numerous pivotal studies, such as CASTLE-AF. It is well recognized that the majority of patients with HF and AF exhibit persistent AF; however, the underlying mechanisms responsible for sustaining persistent AF in this population remain to be fully elucidated. Thus, enhancing ablation success rates in these patients is therefore critical for further reducing morbidity and mortality.
Building on prior research, we have identified driver regions as critical determinants in the maintenance of persistent atrial fibrillation. Moreover, our randomized controlled trials have demonstrated that electro-anatomical ablation may represent the optimal strategy for persistent AF. Based on these findings, we conducted a multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All inclusion criteria must be met to be included in the study.
- •Age: Patients aged 18-80 years, with persistent atrial fibrillation (AF) and heart failure (HF), regardless of ejection fraction (EF).
- •Diagnosis of Heart Failure:
- •Heart Failure with Reduced Ejection Fraction (HFrEF): LVEF ≤ 40%. Heart Failure with Preserved Ejection Fraction (HFpEF): LVEF > 40%, including HFmrEF (LVEF 41-50%).
- •Symptomatic Atrial Fibrillation: Patients with symptomatic persistent AF who have failed or are intolerant to at least one antiarrhythmic drug.
- •NYHA Class II-III: Patients with heart failure classified as NYHA class II-III, who are symptomatic despite optimal medical therapy. Informed Consent: Able to provide written informed consent for participation in the study.
- •Guideline-Recommended Pharmacologic Therapy: Patients who have received and are currently on guideline-recommended pharmacologic therapy for heart failure, including but not limited to ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists (MRAs).
排除标准
- •Any of the following criteria shall be excluded.
- •End-Stage Heart Failure: Patients with heart failure classified as NYHA class IV or with LVEF ≤ 20%.
- •Severe Comorbidities:
- •Patients with severe pulmonary disease (e.g., COPD, severe restrictive lung disease).
- •Severe renal dysfunction (eGFR < 30 mL/min/1.73m²) or advanced liver disease.
- •Active malignancy or other terminal illnesses with a prognosis of less than one year.
- •Inability to Tolerate Ablation:
- •Patients unable to undergo catheter ablation due to anatomical or procedural issues.
- •Patients with contraindications to the procedure, including allergy to contrast agents or inability to tolerate anesthesia.
- •Left atrial thrombus confirmed by preoperative esophageal ultrasound;
- •Uncontrolled Arrhythmias: Patients with persistent or paroxysmal AF who are unable to maintain sinus rhythm despite optimal medical therapy or require frequent hospitalization for arrhythmia control.
- •8. Pregnancy: Pregnant or breastfeeding women.
- •Contraindications to Anticoagulation:
- •Patients who are contraindicated for anticoagulation therapy (e.g., history of major bleeding or bleeding diathesis).
- •11. History of Severe Valve Disease: Patients with a history of severe valve disease and/or prosthetic valve replacement.
- •12. Recent Myocardial Infarction or Stroke: Patients who have had a myocardial infarction or stroke within the past 3 months.
- •13. Contrast Agent Allergy: Patients with a known allergy to contrast agents.
- •Contraindications for Cardiac Catheterization: Any contraindications for cardiac catheterization, including inability to safely perform the procedure.
- •15. Atrial Fibrillation Ablation: Patients who have previously undergone atrial fibrillation ablation.
- •16. Cardiac Surgery: Patients who have undergone any cardiac surgery within the last 2 months.
- •17. Life Expectancy: Patients with a life expectancy of less than 1 year.
研究组 & 干预措施
Anatomical-guided Ablation Group
Patients in the ANAT group would receive anatomical-guided ablation after PVI, including linear ablation and Vein of Marshall (VOM) ethanol infusion.
干预措施: Anatomical-guided Ablation (Procedure)
Electrogram-guided Ablation Group
Patients in the EGM group received target electrogram ablation after PVI while did not receive anatomical-guided ablation. We defined the target electrograms into 4 types as follows.(1) Spatial-temporal Dispersion Activation (2) Locally Short Cycle Length Activity (3) High-Frequency Potentials (4) Focal Activity
干预措施: Electrogram-guided ablation (Procedure)
Extensive Electrogram-Anatomical Guided Ablation Group
Patients in the extensive ablation group (EXT group) would receive EGM-guided ablation firstly. The anatomical-guided ablation would be performed after EGM-guided ablation no matter whether AF terminated during EGM-guided ablation.
干预措施: Extensive electrogram-anatomical guided ablation (Procedure)
结局指标
主要结局
a composite of cardiovascular mortality, hospitalization or urgent visits
时间窗: 12, 18, 24, 36, 46, 60months
The primary endpoint was the incidence of a composite of cardiovascular mortality, hospitalization or urgent visits due to worsening heart failure during the follow-up period after a single catheter ablation procedure
freedom from any documented AF/AT
时间窗: 12, 18, 24, 36, 48, 60months
freedom from any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment
次要结局
- Change in 6-minute walk test(12, 24, 36, 48, 60 months after a single procedure)
- AF burden <1%(12, 24, 36, 48, 60 months after a single procedure)
- Improvement in New York Heart Association (NYHA) functional class(12, 24, 36, 48, 60 months after a single procedure)
- Change in N-terminal pro-B type natriuretic peptide (NT-proBNP)(Month 3,12, 24, 36, 48, 60 after a single procedure)
- Incidence of procedure-related complications(30 days after a single procedure)
研究者
Xu Liu
Dr
Shanghai Chest Hospital