Ireland
--:--IST
Enrolling by invitation Phase 4

Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

NCT05305612 · tracked via the Priya Life Science Poland tracker
Phase
Phase 4
Started
2022-03-13
Last updated
2026-09-17

Condition(s) studied

Mitral RegurgitationAtrial FibrillationAnticoagulation

Investigational drug(s) / intervention(s)

early anticoagulationlate anticoagulation

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years on the day of signing the informed consent form. 2. Planned treatment of mitral regurgitation using the TEER technique (MitraClip or Pascal system) or planned left atrial appendage closure (Watchman system or Amplatzer system). 3. The participant expresses willingness to comply with the study protocol, in particular the protocol-defined follow-up visits. 4. The participant is willing to provide written informed consent to participate in the study. Exclusion Criteria: 1. Pregnant or lactating women, and women of childbearing potential who do not agree to use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implants, injectable depot contraceptives, intrauterine devices, or tubal ligation). This does not apply to women who are postmenopausal (≥ 1 year from last menses) for ≥ 2 years AND, if \< 55 years old, have a negative pregnancy test within 24 hours prior to randomization, or have undergone surgical sterilization. 2. Any diagnosed, acquired, or congenital bleeding or coagulation disorders (e.g., diagnosed thrombophilia, bleeding diatheses). 3. INR \> 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. 4. Last dose of non-vitamin K antagonist oral anticoagulant (NOAC) \< 48 hours before the procedure, in patients receiving NOAC therapy. 5. Last dose of low-molecular-weight heparin (LMWH) \< 12 hours before the procedure, in patients receiving LMWH therapy. 6. Presence of contraindications to brain magnetic resonance imaging (e.g., claustrophobia, metallic implants/prostheses). 7. Presence of cardiac implantable electronic devices (implantable cardioverter-defibrillator \[ICD\], permanent pacemaker, or cardiac resynchronization therapy \[CRT\] system) in the following situations: * Epicardial leads * Left disconnected leads or non-functional or damaged devices * Devices implanted within abdominal wall * Pacemaker dependent patients (Lack of escape rhythm \> 30 bpm). * Patients in whom less than 6 weeks have elapsed since system implantation or replacement. * Patients in whom pre-MRI system interrogation reveals abnormalities in system function or cardiac arrhythmias that, in the opinion of the supervising electrophysiology team, could compromise MRI safety. * Patients whose device battery on the day of the MRI examination has less than 20% voltage between nominal and ERI, or the projected device longevity is less than 1 year.

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)

FacilityCityRegionStatus
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
Official registry record

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