Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly

Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)

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.

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.

Inclusion Criteria:

1. Age ≥ 80 years.
2. Documented paroxysmal or persistent atrial fibrillation by ECG or Holter within 6 months prior to enrollment.
3. Symptomatic AF (including palpitations, chest tightness, fatigue, dizziness, blackouts, dyspnea).
4. Voluntary participation and signed informed consent.

Exclusion Criteria:

1. NYHA Class IV heart failure.
2. Acute myocardial infarction, cardiac surgery, or PCI within the past 1 year.
3. Long-standing persistent AF (duration > 1 year).
4. Left atrial anteroposterior diameter > 6 cm.
5. History of prior AF ablation.
6. AF secondary to reversible causes (e.g., post-surgery, infection, hyperthyroidism).
7. Severe mitral stenosis.
8. Moderate to severe hepatic failure (Child-Pugh B-C).
9. Renal failure stage 4-5 (eGFR <30 ml/min/1.73m2) or continuous dialysis.
10. Inability to cooperate due to dementia or severe mental disorder.
11. Presence of left atrial thrombus.
12. Prior Left Atrial Appendage Occlusion (LAAO).
13. Contraindication to anticoagulation.
14. Life expectancy < 1 year.