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.
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.
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.
Parallel
Catheter Ablation
Procedure/SurgeryPatients undergo PVI (for paroxysmal AF) or PVI +linear ablation+EI-VOM(for persistent AF). All patients will wear eye masks and headphones with music during the procedure.
Sham Control
Procedure/SurgeryPatients undergo femoral vein puncture and catheter placement. Phrenic nerve stimulation is performed to mimic procedural sensations. No ablation energy is delivered. All patients will wear eye masks and headphones with music during the procedure. Patients remain in the lab for at least 60 minutes (for paroxysmal AF) or 90 minutes (for persistent AF).
Change in SF-36 Total Score
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.
Change in AFEQT Score
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
Change in Clinical Frailty Scale (CFS) Score
Change in frailty status assessed by CFS
Change in Left Ventricular Ejection Fraction (LVEF)
Change in NT-proBNP level
Safety Outcome
Composite of all-cause death, stroke, serious adverse events and complications
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