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Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Sponsor: National Institute of Cardiology, Warsaw, Poland
Summary
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.
Official title: Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
410
Start Date
2022-03-13
Completion Date
2025-08
Last Updated
2024-12-10
Healthy Volunteers
No
Interventions
early anticoagulation
Anticoagulation prior to transseptal puncture
late anticoagulation
Anticoagulation after transseptal puncture
Locations (5)
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