NCT05305612

Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation
• Atrial Fibrillation
• Anticoagulation

Interventions

Type	Name	Description
OTHER	early anticoagulation	Anticoagulation prior to transseptal puncture
OTHER	late anticoagulation	Anticoagulation after transseptal puncture

Timeline

• Start date: 2022-03-13
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2022-03-31
• Last updated: 2024-12-10

Locations

5 sites across 1 country: Poland