SAfety and eFfectiveness of cathetER Ablation for Atrial Fibrillation With Intracranial Hemorrhage (SAFER-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 646
- 试验地点
- 7
- 主要终点
- Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism
研究概览
简要总结
SAFER-AF is an investigator-initiated, multicenter, open-label, parallel-group trial comparing catheter ablation versus usual care in patients with atrial fibrillation and intracranial hemorrhage.
详细描述
Atrial fibrillation (AF) increases the risk of stroke, heart failure, and mortality. Oral anticoagulation is the standard treatment for preventing thromboembolism, but it also raises the risk of bleeding. About 20-25% of patients with intracranial hemorrhage have AF. Previous randomized trials indicate that restarting anticoagulation may prevent ischemic stroke, but increase risk of recurrent intracranial hemorrhage. Catheter ablation is the first-line rhythm control strategy that reduce thromboembolic risk by maintaining sinus rhythm and potentially reducing the need for long-term anticoagulation. Pulsed field ablation (PFA) uses electroporation to ablate the myocardium by electroporation with high tissue specificity and may shorten the required anticoagulation period.
The SAFER-AF trial is a prospective, multicenter, open-label randomized controlled trial enrolling 646 AF patients with previous spontaneous intracranial hemorrhage, investigating whether catheter ablation provides superior long-term net clinical benefit compared with usual care. Participants will be randomized 1:1 to catheter ablation versus usual care, with a minimum follow-up of 2 years. Patients in catheter ablation group will undergo PFA, followed by low-dose direct oral anticoagulants for 1 month. The primary endpoint is the composite of all-cause mortality, all-cause stroke (ischemic or hemorrhagic), and systemic embolism. SAFER-AF aims to define a safer, individualized therapeutic pathway balancing ischemic protection and hemorrhagic risk, ultimately improving survival and long-term outcomes for AF patients with intracranial hemorrhage.
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
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years
- •Between 14 Days and 12 Months After Spontaneous Intracranial Hemorrhage (intraparenchymal or intraventricular hemorrhage, and subdural hematoma)
- •Able to Access Intracranial Hemorrhage Imaging Data
- •ECG indicating the presence of atrial fibrillation
- •CHA₂DS₂-VA Score ≥ 2
- •Willing to undergo randomization and able to complete follow-up as required
排除标准
- •Atrial fibrillation secondary to clearly reversible causes (e.g., hyperthyroidism, hypokalemia, etc.)
- •Fully dependent (modified Rankin Scale [mRS] score > 4)
- •Uncontrolled hypertension (systolic blood pressure > 160 mmHg)
- •Presence of uncontrolled active bleeding
- •Presence of active infection requiring antibiotic treatment
- •End-stage renal failure or receiving dialysis treatment
- •Presence of liver failure
- •Untreated coronary artery disease with indication for revascularization
- •Presence of intracardiac masses, thrombi, etc., as evaluated by transthoracic echocardiography or transesophageal echocardiography
- •Expected life expectancy < 1 year (e.g., advanced malignant tumors, etc.)
- •Pregnant, lactating, or women planning to become pregnant
- •Presence of psychological or psychiatric disorders that prevent understanding or cooperation with the study
- •Other conditions deemed unsuitable for participation in the study by the investigators
研究组 & 干预措施
Usual care Group
干预措施: Usual Care (Drug)
Catheter Ablation Group
干预措施: Catheter Ablation (Procedure)
结局指标
主要结局
Composite of All-Cause Mortality, All-Cause Stroke, and Systemic Embolism
时间窗: 48 months
次要结局
- Intracranial Hemorrhage(48 months)
- Clinically relevant non-major bleeding(48 months)
- modified Rankin Scale score(48 months)
- Cardiovascular death(48 months)
- ISTH Major Bleeding(48 months)
- Stroke and Systemic Embolism(48 months)
- Ischemic Stroke(48 months)
- Change in health-related quality of life assessed by the EQ-5D-5L questionnaire(48 months)
- Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)(48 months)
研究者
Chang sheng Ma
Director of Cardiology Department
Beijing Anzhen Hospital