Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillatio
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 ove
| Condition(s) | Atrial Fibrillation (AF) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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) o |
| Ages | 80 Years |
| Sex | All |
| Lead sponsor | Beijing Anzhen Hospital |
| Locations | Beijing, China |
| Start date | 2026-01-30 |
| NCT ID | NCT07403760 |
| Official listing | https://clinicaltrials.gov/study/NCT07403760 |