Comparing LAA clipping to NOACs for stroke prevention in 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

This trial investigates whether thoracoscopic left atrial appendage (LAA) clipping is more effective than novel oral anticoagulants (NOACs) in preventing stroke and other complications in patients with non-paroxysmal atrial fibrillation who are at high risk for embolism. The study focuses on patients who have persistent or long-standing persistent AF and are not undergoing ablation. It aims to address the challenges of long-term anticoagulation therapy, including adherence issues and bleeding risks associated with NOACs. By exploring LAA clipping as an alternative, the trial seeks to provide insights into a potentially safer and more effective treatment strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Persistent or long-standing persistent AF documented by medical history or direct electrocardiogram.
* CHA2DS2-VASc ≥2 in men and ≥3 in women.
* Agree to perform thoracoscopic LAA occlusion procedure.

Exclusion Criteria:

* With electrical cardioversion or ablation intent.
* Other heart diseases with surgical indications.
* Ischemic stroke and other cardiac embolic events within 30 days.
* Major clinical bleeding event within 30 days.
* Contraindications to anticoagulation.
* Intracardiac thrombus.
* Left ventricular ejection fraction (LVEF) \< 30%.
* Active systemic infection or infective endocarditis or pericarditis
* Severe liver disease (acute clinical hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT)/ aspartate transaminase (AST) greater than 3 times the upper limit of normal value.
* Severe renal insufficiency (eGFR ≤ 30mL/min).
* Other diseases requiring oral anticoagulants.
* Active aortic plaque.
* Acute coronary syndrome within 3 months.
* Symptomatic carotid artery stenosis.
* Patients requiring dual antiplatelet drug therapy.
* Previous cardiac and left lung surgery.
* Severe left pleural and pericardial adhesions.
* Pregnant or breastfeeding patients.
* Metal allergies.
* Terminal illness with a life expectancy of less than 2 years.
* Participation in other clinical studies at the time of enrollment.
* Refuse to participate in this study.

Where it's running

• China National Center for Cardiovascular Diseases
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhe Zheng, MD,PhD
• Email: zhengzhe@fuwai.com
• Phone: +86-010-88396051

Similar studies

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

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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.