Ablation to improve wellbeing and survival in people aged 80 and older with atrial fibrillation

Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)

This will see if catheter ablation, compared with a sham procedure, improves quality of life over six months for people aged 80 and older with symptomatic atrial fibrillation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 80 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07403760 on ClinicalTrials.gov

What this trial studies

WISER-AF is a multicenter, double-blind, sham-controlled randomized trial enrolling 182 symptomatic patients aged 80 or older in Beijing, China. Participants are randomized 1:1 to pulsed field catheter ablation or a sham procedure, with blinding supported by eye masks, headphones, and phrenic nerve stimulation in the sham arm. The primary outcome is change in the SF-36 total score from baseline to six months, and secondary outcomes include AFEQT, Clinical Frailty Scale, LVEF, NT-proBNP, 6-minute walk distance, and cardiovascular events. The design focuses on patient-reported quality of life and functional measures rather than only rhythm outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 80 or older with documented paroxysmal or persistent symptomatic AF who can give informed consent and meet procedural safety criteria.

Not a fit: Patients with long-standing persistent AF, advanced heart failure (NYHA IV), significant organ failure, left atrial thrombus, prior AF ablation, or other listed exclusion criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, ablation could meaningfully improve symptoms and overall quality of life for very elderly patients with symptomatic atrial fibrillation.

How similar studies have performed: Previous ablation trials in broader AF populations have shown symptom and quality-of-life benefits, but sham-controlled data specifically in people aged 80 and older are limited, making this approach relatively novel for the very elderly.

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 \<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.

Where this trial is running

Beijing

• Beijing Anzhen Hospital, Capital Medical University, Beijing, China — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Changsheng Ma, Prof. — Beijing Anzhen Hospital
• Study coordinator: Liu He, PhD

Conditions Atrial Fibrillation; catheter ablation; very elderly; quality of life