The transcatheter edge to edge mitral valve repair (TEER) and left atrial appendage closure (LAAC) are the interventional cardiology procedures that require periprocedural anticoagulation with unfractionated heparin (UFH). The UFH is administered either before or immediately after transseptal puncture, at the discretion of the operator The aim of the study is to establish the optimal timing of initiation of periprocedural anticoagulation in patients undergoing structural heart interventions requiring transseptal puncture (TEER and LAAC), Patients who undergo TEER implantation or LAAC procedure will be randomized to two groups: 1. Early UFH administration. The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP. 2. Late UFH administration. The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
410
Anticoagulation prior to transseptal puncture
Anticoagulation after transseptal puncture
Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny
Gdansk, Poland
Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego
Katowice, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
1. MACCE 2. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography 3. Occurrence of new ischemic lesions with diameter ≥4 mm in brain MR performed 2-5 days after procedure
Major adverse cardiac and cerebrovascular events (MACCE) will include: death (all-cause and cardiovascular), stroke, TIA, non-fatal myocardial infarction or peripheral embolization, within 30 days from the index procedure.
Time frame: Within 30 days from the index procedure
Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization
Time frame: during the hospitalization related to the index procedure but up to 30 days from randomization
Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography
Time frame: during index procedure
Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure.
Time frame: within 2-5 days post index procedure
Major adverse cardiac and cerebrovascular events death (all-cause and cardiovascular), stroke, TIA, non-fatal myocardial infarction or peripheral embolization, within 30 days from the index procedure.
Time frame: within 30 days from index procedure
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