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

Summary

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.

Eligibility

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.

Conditions2

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