Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly
Recruiting · NCT07403760 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Anzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Catheter AblationSham Control
What this trial is about
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 take part
Age range
80 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- History of prior AF ablation.
- AF secondary to reversible causes (e.g., post-surgery, infection, hyperthyroidism).
- Severe mitral stenosis.
- Moderate to severe hepatic failure (Child-Pugh B-C).
- Renal failure stage 4-5 (eGFR \<30 ml/min/1.73m2) or continuous dialysis.
- Inability to cooperate due to dementia or severe mental disorder.
- Presence of left atrial thrombus.
- Prior Left Atrial Appendage Occlusion (LAAO).
- Contraindication to anticoagulation.
- Life expectancy \< 1 year.
Where it is running
1 location listed.
- Beijing Anzhen Hospital, Capital Medical University, Beijing, China - Beijing, China