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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a procedure called catheter ablation (a minimally invasive heart procedure that corrects abnormal electrical signals) improves health and survival in people aged 80 or older with atrial fibrillation (an irregular heartbeat). **You may be eligible if...** - You are 80 years old or older - You have documented atrial fibrillation (paroxysmal or persistent) confirmed by ECG or Holter monitor in the past 6 months - You experience symptoms such as palpitations, chest tightness, fatigue, dizziness, or breathlessness **You may NOT be eligible if...** - You have very severe heart failure (NYHA class IV) - You had a heart attack, heart surgery, or stent procedure in the past year - Your atrial fibrillation has been continuous for more than 1 year - You have had a prior ablation for atrial fibrillation - You have severe mitral valve narrowing or advanced liver or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.