Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

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.

NCT Number	NCT05305612
Lead Sponsor	National Institute of Cardiology, Warsaw, Poland Collaborators: Medical Research Agency, Poland, Soft Communication, Poland
Conditions	Mitral Regurgitation, Atrial Fibrillation, Anticoagulation
Enrollment	410 participants
Start Date	2022-03-13
Primary Completion	2025-05 (estimated)
Study Completion	2025-08 (estimated)
Updated on ClinicalTrials.gov	2024-12-10