Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of Left atrial appendage closure compared to standard antiplatelet therapy in patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to evaluate the safety and efficacy of implantation of left atrial appendage closure compared to standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in subjects with AF who underwent PCI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborator: Boston Scientific Corporation
• Treatments: Aspirin; Clopidogrel; Warfarin

Criteria

Inclusion criteria:

• age > 18 years old

• Acute coronary syndrome without ST elevation and unstable angina 2 weeks before enrolment

• Successful PCI procedure with DES

• History of atrial fibrillation (paroxysmal, persistent or permanent) with ECG documentation within previous 12 month

• CHA2DS2-VASC ≥ 2

• HAS-BLED ≥ 3

• LAA eligible for left atrial appendage closure device implantation (TEE data)

Exclusion criteria:

• age <18 or >80 years old

• INR >3

• recurrent myocardial infarction

• myocardial infarction with ST elevation

• EF<50%

• severe comorbidities

• Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.

• anemia < 100 g/l

• uncontrolled hypertension

• thrombocytopenia

• oncology

• obesity, BMI>40

• LAA thrombosis

• Women of childbearing potential (unless post-menopausal or surgically sterile)