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| Name | Class |
|---|---|
| Medical Research Agency, Poland | OTHER_GOV |
| Soft Communication, Poland | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early UFH administration | Experimental | 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. |
|
| Late UFH administration | Active Comparator | The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early anticoagulation | Other | Anticoagulation prior to transseptal puncture |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Major adverse cardiac and cerebrovascular events (MACCE) will include: death, stroke, TIA, peripheral embolization, myocardial infarction within 30 days from the index procedure. | Within 30 days from the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization | during the hospitalization related to the index procedure but up to 30 days from randomization | |
| Intraprocedural fresh thrombus formation in the right of left atrium as assessed with periprocedural transsesophageal echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.
Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis, thrombocyopenia with platelet count <50 thousand/ml, INR elevated >1.5 in the last test prior to randomization)
INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. (applies to the last INR value prior to randomization)
Last dose of new oral anticoagulant < 48 hours prior to the procedure (assessed at randomization)
Last dose of low molecular weight heparin <12 hours prior to the procedure (assessed at randomization)
Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic intraocular foreign boddies, ferromagnetic metalic prostheses)
Implanted cardiac devices for electrotherapy if:
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| Name | Affiliation | Role |
|---|---|---|
| Jerzy Pręgowski, MD, PhD | National Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny | Gdansk | 80-952 | Poland | |||
| Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38401649 | Derived | Pregowski J, Pracon R, Mioduszewska A, Skowronski J, Sondergaard L, Mintz GS, Capodanno D, Kim SW, De Baker O, Wacinski P, Wojakowski W, Rdzanek A, Grygier M, Chmielecki M, Franco LN, Stoklosa P, Firek B, Marczak M, Milosz B, Chmielak Z, Demkow M, Witkowski A. Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial. Am Heart J. 2024 May;271:68-75. doi: 10.1016/j.ahj.2024.02.015. Epub 2024 Feb 22. |
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to be defined
IPD sharing will be considered after study completion and publication of the results.
to be defined
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
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Patients will be randomized to:
Early unfractionated heparin 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.
Late unfractionated heparin 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.
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The study will be conducted by blinded and unblinded staff. The participants, investigators, care provider and outcome assessors will be blinded. However, in every center the dedicated unblinded study nurse will randomize the patient and prepare two syringes either with saline or UFH. The syringes will be labeled with number 1 and number 2 and will be provided to the anestesiologist taking care of patient during the procedure. The injection from syringe nr 1 will be administered after obtaining the venous access and 5 minutes before the start of TSP. The injection from syringe nr 2 will be administered after TSP defined as introduction of trans-septal sheath into the left atrium. The unblinding nurse responsible for the randomization procedure and preparation of syringe nr 1 and syringe nr 2 and will be not involved in any other procedures or care of the patients enrolled into the study.
| late anticoagulation |
| Other |
Anticoagulation after transseptal puncture |
|
| during index procedure |
| Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure. | within 2-5 days post index procedure |
| Major adverse cardiac and cerebrovascular events (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index procedure. | within 30 days from index procedure |
| Katowice |
| Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | 60-355 | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | Poland |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |