RECRUITINGINTERVENTIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

Catheter 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.

PROCEDURE

Sham 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.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China