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Compares treatment options for Non-paroxysmal Atrial Fibrillation
Official title LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.
ClinicalTrials.gov ID: NCT06021808
What this study is testing
What is Novel oral anticoagulant?
Novel oral anticoagulant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-paroxysmal atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.