NCT06021808Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- First submitted
- 28 Aug 2023
- Start date
- 2 Apr 2024
- Primary completion date
- Apr 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT06021808
What you commit to
- Study type: Interventional
- Planned participants: 290
- From 2 Apr 2024 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring dual antiplatelet drug therapy.
- Previous cardiac and left lung surgery.
Other illness
- Other heart diseases with surgical indications.
- Ischemic stroke and other cardiac embolic events within 30 days.
- Major clinical bleeding event within 30 days.
- Active systemic infection or infective endocarditis or pericarditis
- Other diseases requiring oral anticoagulants.
- Acute coronary syndrome within 3 months.
- Metal allergies.
- Terminal illness with a life expectancy of less than 2 years.
Lab values
- Left ventricular ejection fraction (LVEF) \< 30%.
- 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
- With electrical cardioversion or ablation intent.
- Contraindications to anticoagulation.
- Intracardiac thrombus.
- Active aortic plaque.
- Symptomatic carotid artery stenosis.
- Severe left pleural and pericardial adhesions.
- Pregnant or breastfeeding patients.
- Participation in other clinical studies at the time of enrollment.
- Refuse to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China National Center for Cardiovascular Diseases Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.