periprocedural anticoagulant treatment in patients treated with TEER or transcatheter left atrial appendage closure surgery
Conditions
Brief summary
The primary efficacy endpoint is a composite of the following: 1 major adverse cardiac and cerebrovascular events (MACCE; death, stroke, transient ischemic attack [TIA], myocardial infarction, or peripheral embolization) within 30 days after procedure; 2 intraprocedural new thrombus formation in the right or left atrium as assessed with periprocedural TEE; or 3 occurrence of new ischemic lesions with diameter ≥4 mm on brain MRI performed 2 to 5 days after the procedure.
Detailed description
The secondary/efficacy safety endpoint: moderate or severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization; 1 intraprocedural new thrombus formation in the right or left atrium as assessed by periprocedural TEE; 2 occurrence of new ischemic brain lesions on MRI performed within 2 to 5 days after the index procedure; or 3 MACCE (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index
Interventions
DRUGHEPARINUM WZF
DRUG5 000 IU/ml
DRUGPHYSIOLOGICAL SALINE SOLUTION: Injectio Natrii Chlorati Isotonica Polpharma
DRUG9 mg/ml
Sponsors
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is a composite of the following: 1 major adverse cardiac and cerebrovascular events (MACCE; death, stroke, transient ischemic attack [TIA], myocardial infarction, or peripheral embolization) within 30 days after procedure; 2 intraprocedural new thrombus formation in the right or left atrium as assessed with periprocedural TEE; or 3 occurrence of new ischemic lesions with diameter ≥4 mm on brain MRI performed 2 to 5 days after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary/efficacy safety endpoint: moderate or severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization; 1 intraprocedural new thrombus formation in the right or left atrium as assessed by periprocedural TEE; 2 occurrence of new ischemic brain lesions on MRI performed within 2 to 5 days after the index procedure; or 3 MACCE (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index | — |
Countries
Poland
Outcome results
None listed