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Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

NCT05305612 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2024-12-10

No results posted yet for this study

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

Interventions

OTHER

early anticoagulation

Anticoagulation prior to transseptal puncture

OTHER

late anticoagulation

Anticoagulation after transseptal puncture

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • Soft Communication, Poland

    collaborator UNKNOWN

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Jerzy Pręgowski, MD, PhD · National Institute of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-13
Primary Completion
2025-05-31
Completion
2025-08-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305612 on ClinicalTrials.gov