Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly

Beijing Anzhen Hospital182 enrolled

Overview

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.

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 182 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either pulsed field ablation (PFA) 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, 6-minute walk distance, and cardiovascular events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

182

Conditions

Atrial Fibrillation (AF)

Interventions

Catheter AblationPROCEDURE

Patients undergo PVI (for paroxysmal AF) or PVI +linear ablation+EI-VOM(for persistent AF) using pulsed field ablation catheters. All patients will wear eye masks and headphones with music during the procedure.

Sham ControlPROCEDURE

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 80 minutes.

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Change in SF-36 Total Score

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.