Atrial Fibrillation (AF)
Conditions
Keywords
catheter ablation, very elderly, quality of life
Brief 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.
Detailed description
Atrial fibrillation (AF) prevalence increases with age, posing significant challenges in the very elderly (≥80 years). While catheter ablation is an established treatment for general AF patients, its efficacy in improving quality of life (QoL) in the very elderly remains underrepresented in previous trials. The WISER-AF trial is designed to fill this evidence gap. The study will enroll 136 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either catheter ablation or a sham procedure. To ensure blinding, all patients will wear eye masks and headphones during the procedure. The sham group will receive phrenic nerve stimulation to mimic the sensation of ablation without delivering therapeutic energy. The primary endpoint is the change in the SF-36 total score from baseline to 6 months. Secondary endpoints include changes in AFEQT score, Clinical Frailty Scale (CFS), LVEF, NT-proBNP, and cardiovascular events.
Interventions
PROCEDURECatheter Ablation
Patients 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.
PROCEDURESham Control
Patients 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).
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
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) or continuous dialysis. 10. Inability to cooperate due to dementia or severe mental disorder. 11. Presence of left atrial thrombus. 12. Prior Left Atrial Appendage Occlusion (LAAO). 13. Contraindication to anticoagulation. 14. Life expectancy \< 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SF-36 Total Score | Baseline, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AFEQT Score | Baseline, 6 months | Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score |
| Change in Clinical Frailty Scale (CFS) Score | Baseline, 6 months | Change in frailty status assessed by CFS |
| Change in Left Ventricular Ejection Fraction (LVEF) | Baseline, 6 months | — |
| Change in NT-proBNP level | Baseline, 6 months | — |
| Freedom from Atrial Arrhythmias | 6 months | Absence of atrial fibrillation, atrial flutter, or atrial tachycardia recorded by ECG, Holter, or patch monitor after a 30-day blanking period. |
| Incidence of Composite Cardiovascular Outcome | 6 months | Composite of all-cause death, stroke or systemic embolism, myocardial infarction, major bleeding, and heart failure hospitalization/emergency visits. |
| Healthcare Resource Utilization | 6 months | Number of emergency room visits and unplanned hospitalizations |
Countries
China
Contacts
CONTACTLiu He, PhD
PRINCIPAL_INVESTIGATORChangsheng Ma, Prof.
Beijing Anzhen Hospital
PRINCIPAL_INVESTIGATORNing Zhou, Prof.
Beijing Anzhen Hospital
Outcome results
None listed