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NCT07403760
Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly
Conditions: Atrial Fibrillation (AF)
Sex: All
Ages: 80 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 136
Sponsor: Beijing Anzhen Hospital
Location: Beijing Anzhen Hospital, Capital Medical University, Beijing, China Beijing
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07403760). StuddyBuddy aggregates publicly available trial information.
