Sponsor study identifier
interventional
290
1 country
1
Study Start
April 2, 2024
Actual (reported)Primary Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2023
Actual (reported)September 1, 2023
Actual (reported)April 2, 2024
Actual (reported)April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rate of composite endpoint
Stroke, systemic embolism, all-cause mortality, major bleeding event, and clinically relevant non-major bleeding event.
At 24-month after intervention
Rate of stroke
At 24-month after intervention
Rate of systemic embolism
At 24-month after intervention
Rate of all-cause mortality
At 24-month after intervention
Rate of major bleeding event
At 24-month after intervention
Rate of clinically relevant non-major bleeding event
At 24-month after intervention
In this arm, participants are performed thoracoscopic LAA clipping.
Patients randomized to NOAC therapy will begin long-term oral administration of NOACs immediately after enrollment.
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.
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.
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
Yu C, Li H, Lei C, Wang Y, Chen S, Zhao Y, Zheng Z. Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Mar 5;14(3):e083153. doi: 10.1136/bmjopen-2023-083153.
Zhe Zheng, MD,PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
First Submitted
August 28, 2023
First Posted
September 1, 2023
Study Start
April 2, 2024
Actual (reported)Primary Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 13, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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