Comparing LAA clipping to NOACs for stroke prevention in atrial fibrillation

Epicardial Left Atrial Appendage Clipping Versus Novel Oral Anticoagulants to Reduce Stroke Risk in Non-paroxysmal Atrial Fibrillation: a Multicenter Randomized Controlled Trial

This study is testing if a procedure called LAA clipping can prevent strokes better than blood thinners in people with long-term atrial fibrillation who are at high risk for blood clots.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06021808 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with persistent or long-standing persistent atrial fibrillation and a CHA2DS2-VASc score of 2 or higher in men and 3 or higher in women.

Not a fit: Patients who have undergone electrical cardioversion or ablation, or those with contraindications to anticoagulation, will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a safer alternative to anticoagulants for stroke prevention in high-risk atrial fibrillation patients.

How similar studies have performed: While the concept of LAA closure has been explored in other studies, this specific comparison of LAA clipping versus NOACs is a novel approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• China National Center for Cardiovascular Diseases — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhe Zheng, MD,PhD

Conditions Non-paroxysmal Atrial Fibrillation; left atrial appendage clipping; Stroke; Oral anticoagulation; Atrial Fibrillation