RecruitingNot ApplicableNCT06021808

LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal 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

Sponsor

China National Center for Cardiovascular Diseases

Enrollment

290 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Non-paroxysmal Atrial Fibrillation

Summary

This trial is designed to examine the hypothesis that thoracoscopic LAA clipping is superior to NOACs for stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant nonmajor bleeding events in AF patients at high risk of embolism (CHA2DS2-VASc ≥2 in men and ≥3 in women) that are not undergoing ablation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two approaches to prevent stroke in people with persistent (non-paroxysmal) atrial fibrillation: surgically clipping off the left atrial appendage (LAA, a small pouch in the heart where clots form) versus taking blood thinners (NOACs) long-term. **You may be eligible if...** - You are 18 or older - You have persistent or long-standing persistent atrial fibrillation documented by ECG - Your stroke risk score (CHA2DS2-VASc) is 2 or higher for men, 3 or higher for women - You are willing to undergo the LAA clipping procedure **You may NOT be eligible if...** - You are planning cardioversion or ablation - You have had a stroke or major bleeding event within the past 30 days - You have a blood clot in the heart, severely reduced heart function (LVEF below 30%), or severe liver or kidney disease - You are pregnant or breastfeeding - You have a terminal illness with less than 2 years' life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREThoracoscopic LAA clipping

The surgeons measured the length of the base of the LAA, an appropriately sized LAA clip is then inserted with the aid of a thoracoscope and placed parallel to the base of the LAA.

DRUGNovel oral anticoagulant

For patients with creatinine clearance ≥50 ml/min, oral rivaroxaban 20 mg daily was administered, whereas for patients with creatinine clearance between 30-49 ml/min, oral rivaroxaban 15 mg daily was administered.

Locations(1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

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NCT06021808