Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Condition(s) studied
Investigational drug(s) / intervention(s)
early anticoagulation: Anticoagulation prior to transseptal puncture
late anticoagulation: Anticoagulation after transseptal puncture
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.
Eligibility
Primary outcome measure(s)
- 1. MACCE 2. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography 3. Occurrence of new ischemic lesions with diameter ≥4 mm in brain MR performed 2-5 days after procedure — Within 30 days from the index procedure
Major adverse cardiac and cerebrovascular events (MACCE) will include: death (all-cause and cardiovascular), stroke, TIA, non-fatal myocardial infarction or peripheral embolization, within 30 days from the index procedure.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05305612 on ClinicalTrials.gov ↗ ← All trials in Poland