Comparing left atrial appendage occlusion and novel oral anticoagulants in patients with atrial fibrillation undergoing PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and safety of left atrial appendage occlusion (LAAO) compared to novel oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI). It aims to balance the risks of ischemic events and bleeding complications, which are heightened in this patient population due to shared risk factors. The study will involve patients who meet specific inclusion criteria, including successful PCI and the presence of certain comorbidities. Participants will be treated with either the WATCHMAN device or a combination of anticoagulant and antiplatelet medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Successful PCI for unstable angina or CCS
2. Non-valvular atrial fibrillation
3. Concomitant at least one of the following conditions: congestive heart failure, hypertension, ≥65yrs, diabetes, previous stroke, TIA or thromboembolism
4. Eligible for long-term novel oral anti-coagulation (NOAC) therapy
5. Able to understand and provide informed consent and comply with all study procedures/medications

Exclusion Criteria:

Patients who meet any of the following criteria will be disqualified from participation in the study:

Clinical exclusion criteria:

1. Under the age of 18
2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
4. Concurrent medical condition with a life expectancy of less than 3 years
5. Haemodynamical unstable
6. Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
7. PCI for ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), or experienced a peri-procedural myocardial infarction (MI) caused by PCI
8. Known contraindication to LAAO or LAAO is not required
9. Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted a mechanical valve)
10. The patient had or is planning to have any cardiac (excluding the current PCI procedure) or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., cardioversion, ablation, cataract surgery)
11. Ongoing overt bleeding
12. Previous stroke/TIA within 30 days of enrolment
13. Symptomatic carotid artery disease
14. Severe renal insufficiency (CrCl≤30ml/min)

Imaging Exclusion Criteria:

1. Left atrial appendage (LAA) thrombus
2. High risk patent foramen ovale or atrial septal defect requiring invasive treatment
3. Anatomical unsuitable for LAAO
4. Rheumatic heart valve disease, mitral valve stenosis (valve area \<1.5cm2)

Where it's running

• Ling Tao
  Xi'an, Shannxi, China Recruiting

Study contacts

• Study coordinator: Chao Gao, M.D., Ph.D.
• Email: woshigaochao@gmail.com
• Phone: +86-18629551066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Pilates breathing vs diaphragmatic breathing after PCI

  This study tests whether Pilates breathing or diaphragmatic breathing helps improve oxygen levels and heart-rate variability in people who just had PCI.

  Recruiting Foundation University Islamabad · Rawalpindi · NCT07872098

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Aspirin 50 mg vs 100 mg with a P2Y12 inhibitor after PCI

  This trial tests whether a 50 mg daily aspirin dose, when used with a P2Y12 inhibitor after PCI, works as well as 100 mg with similar safety for people staying on DAPT for 12 months.

  Recruiting Jilin University · Changchun, Jilin · NCT07846462

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.