Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in SF-36 Total Score
研究概览
简要总结
The WISER-AF trial is a multicenter, double-blind, sham-controlled, randomized controlled trial. It aims to evaluate the efficacy and safety of catheter ablation compared to a sham procedure in improving the quality of life (SF-36 score) in very elderly patients (aged ≥80 years) with symptomatic atrial fibrillation over a 6-month follow-up period.
详细描述
Atrial fibrillation (AF) prevalence increases with age, posing significant challenges in the very elderly (≥80 years). While catheter ablation is an established treatment for general AF patients, its efficacy in improving quality of life (QoL) in the very elderly remains underrepresented in previous trials. The WISER-AF trial is designed to fill this evidence gap. The study will enroll 136 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either catheter ablation or a sham procedure. To ensure blinding, all patients will wear eye masks and headphones during the procedure. The sham group will receive phrenic nerve stimulation to mimic the sensation of ablation without delivering therapeutic energy. The primary endpoint is the change in the SF-36 total score from baseline to 6 months. Secondary endpoints include changes in AFEQT score, Clinical Frailty Scale (CFS), LVEF, NT-proBNP, and cardiovascular events.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 80 years.
- •Documented paroxysmal or persistent atrial fibrillation by ECG or Holter within 6 months prior to enrollment.
- •Symptomatic AF (including palpitations, chest tightness, fatigue, dizziness, blackouts, dyspnea).
- •Voluntary participation and signed informed consent.
排除标准
- •NYHA Class IV heart failure.
- •Acute myocardial infarction, cardiac surgery, or PCI within the past 1 year.
- •Long-standing persistent AF (duration > 1 year).
- •Left atrial anteroposterior diameter > 6 cm.
- •History of prior AF ablation.
- •AF secondary to reversible causes (e.g., post-surgery, infection, hyperthyroidism).
- •Severe mitral stenosis.
- •Moderate to severe hepatic failure (Child-Pugh B-C).
- •Renal failure stage 4-5 (eGFR <30 ml/min/1.73m2) or continuous dialysis.
- •Inability to cooperate due to dementia or severe mental disorder.
- •Presence of left atrial thrombus.
- •Prior Left Atrial Appendage Occlusion (LAAO).
- •Contraindication to anticoagulation.
- •Life expectancy < 1 year.
研究组 & 干预措施
Catheter Ablation Group
干预措施: Catheter Ablation (Procedure)
Sham Control Group
干预措施: Sham Control (Procedure)
结局指标
主要结局
Change in SF-36 Total Score
时间窗: Baseline, 6 months
Difference in the change of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) total score from baseline to 6 months between the two groups.
次要结局
- Change in AFEQT Score(Baseline, 6 months)
- Change in Clinical Frailty Scale (CFS) Score(Baseline, 6 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(Baseline, 6 months)
- Change in NT-proBNP level(Baseline, 6 months)
- Change in 6-Minute Walk Distance (6MWT)(Baseline, 6 months)
- Freedom from Atrial Arrhythmias(6 months)
- Incidence of Composite Cardiovascular Outcome(6 months)
- Healthcare Resource Utilization(6 months)
- Serious Adverse Events(6 months)