Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Catheter Ablation, Sham Control.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)
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.
Detailed description
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 136 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either catheter ablation 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, and cardiovascular events.
Interventions
- Procedure Catheter Ablation
Patients undergo PVI (for paroxysmal AF) or PVI +linear ablation+EI-VOM(for persistent AF). 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 60 minutes (for paroxysmal AF) or 90 minutes (for persistent AF).
Primary outcome measures
- Change in SF-36 Total Score [Time frame: Baseline, 6 months]
Secondary outcome measures (7)
- Change in AFEQT Score [Time frame: Baseline, 6 months]
- Change in Clinical Frailty Scale (CFS) Score [Time frame: Baseline, 6 months]
- Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline, 6 months]
- Change in NT-proBNP level [Time frame: Baseline, 6 months]
- Freedom from Atrial Arrhythmias [Time frame: 6 months]
- Incidence of Composite Cardiovascular Outcome [Time frame: 6 months]
- Healthcare Resource Utilization [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital, Capital Medical University, Beijing, China — Beijing
Identifiers
NCT: NCT07403760 · KS202607