Ablation to improve wellbeing and survival in people aged 80 and older with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

WISER-AF is a multicenter, double-blind, sham-controlled randomized trial enrolling 182 symptomatic patients aged 80 or older in Beijing, China. Participants are randomized 1:1 to pulsed field catheter ablation or a sham procedure, with blinding supported by eye masks, headphones, and phrenic nerve stimulation in the sham arm. The primary outcome is change in the SF-36 total score from baseline to six months, and secondary outcomes include AFEQT, Clinical Frailty Scale, LVEF, NT-proBNP, 6-minute walk distance, and cardiovascular events. The design focuses on patient-reported quality of life and functional measures rather than only rhythm outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University, Beijing, China
  Beijing, China Recruiting

Study contacts

• Principal investigator: Changsheng Ma, Prof. — Beijing Anzhen Hospital
• Study coordinator: Liu He, PhD
• Email: theliu@139.com
• Phone: +86 13810720787

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulsed Field vs Cryoballoon for Pulmonary Vein Isolation in Atrial Fibrillation

  This trial tests whether pulsed field ablation can shorten the procedure for first-time PVI in AF patients compared with cryoballoon ablation, while keeping safety and effectiveness similar.

  Recruiting St. Josefs-Hospital Wiesbaden GmbH · Wiesbaden · NCT07910370

• Pulsed Field Ablation vs Cryoablation for Atrial Fibrillation Under Deep Sedation

  This trial tests whether pulsed field ablation (PFA) done under deep sedation works as well as cryoballoon ablation for treating atrial fibrillation, aiming to avoid general anesthesia.

  Recruiting East Sussex Healthcare NHS Trust · Eastbourne · NCT07900685

• Bachmann’s Bundle Pacing vs Right Atrial Appendage Pacing for AF

  This study tests two common atrial pacing methods to see which one is safer over 12 months for people getting a new pacemaker, ICD, or CRT device.

  Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07874763

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

• Pace-and-ablate strategy in atrial fibrillation: who benefits and long-term outcomes

  This study looks at adults with atrial fibrillation who underwent AV node ablation with permanent pacing to see who develops pacing-induced problems and how they do long-term.

  Recruiting at 5 sites Insel Gruppe AG, University Hospital Bern · Zabrze and 4 other locations · NCT07852221

• AI-based cardiac analysis using 12-lead and 1-lead ECG

  A clinician-facing pilot test to see if SmartECG-EF helps evaluate heart function using both 12-lead and single-lead ECGs in adults with heart conditions.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07844434

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.