RecruitingNot ApplicableNCT07403760

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

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

Sponsor

Beijing Anzhen Hospital

Enrollment

182 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

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

Min Age: 80 Years

Inclusion Criteria4

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 Criteria14

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.

Interventions

PROCEDURECatheter Ablation

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.

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 80 minutes.