LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.

NCT06021808 | Recruiting DMC

• 1 other identifier: 2023-2059
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-paroxysmal Atrial Fibrillation

Keywords

left atrial appendage clipping; Stroke; Oral anticoagulation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

LAA clipping group

EXPERIMENTAL

In this arm, participants are performed thoracoscopic LAA clipping.

Procedure: Thoracoscopic LAA clipping

NOACs group

ACTIVE COMPARATOR

Patients randomized to NOAC therapy will begin long-term oral administration of NOACs immediately after enrollment.

Drug: Novel oral anticoagulant

Interventions

Thoracoscopic LAA clipping PROCEDURE

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.

LAA clipping group

Novel oral anticoagulant DRUG

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.

NOACs group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38448081 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhe Zheng, MD,PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Zhe Zheng, MD,PhD

CONTACT

+86-010-88396051; zhengzhe@fuwai.com

Chunyu Yu, MD

CONTACT

yuchunyu@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start: April 2, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)