STOP CLOT


Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT Trial)


Description of the study: The aim of the study is to compare efficacy and safety of two strategies of initiation of anticoagulation with unfractionated heparin (UFH) in patients undergoing structural heart interventions requiring transseptal puncture (MitraClip implantation or Left Atrial Appendage Closure). Patients will be randomized to:

  • Early UFH administration. The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 15 minutes prior to the start of the transseptal puncture or
  • Late UFH administration. The iv. bolus of UFH (100Units/kg) will be given immediately after transseptal puncture, defined as the introduction of the transseptal sheath into the left atrium.
 
Sponsor:
National Institute of Cardiology

Protocol number:
ABM/2020/1/00002

EudraCT number:
2021-000442-18

Project Manager/Main Investigator:
dr hab. Jerzy Pręgowski, prof. inst.

Duration of the study:
2021 - 2026

Study phase:
IV

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