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ENROLLING BY INVITATION
NCT05305612
PHASE4

Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Sponsor: National Institute of Cardiology, Warsaw, Poland

View on ClinicalTrials.gov

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

OTHER

early anticoagulation

Anticoagulation prior to transseptal puncture

OTHER

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