early anticoagulation
OtherAnticoagulation prior to transseptal puncture
NCT Number: NCT05305612
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny, Gdansk, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anticoagulation prior to transseptal puncture
Anticoagulation after transseptal puncture
Time frame: Within 30 days from the index procedure
Major adverse cardiac and cerebrovascular events (MACCE) will include: death, stroke, TIA, peripheral embolization, myocardial infarction within 30 days from the index procedure.
Time frame: during the hospitalization related to the index procedure but up to 30 days from randomization
Time frame: during index procedure
Time frame: within 2-5 days post index procedure
Time frame: within 30 days from index procedure
National Institute of Cardiology, Warsaw, Poland
Other
Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Acronym: STOP CLOT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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