About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Catheter Ablation
- Sham Control