Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 410
- 试验地点
- 8
- 主要终点
- 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
研究概览
简要总结
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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 at least 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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years on the day of signing the informed consent form.
- •Planned treatment of mitral regurgitation using the TEER technique (MitraClip or Pascal system) or planned left atrial appendage closure (Watchman system or Amplatzer system).
- •The participant expresses willingness to comply with the study protocol, in particular the protocol-defined follow-up visits.
- •The participant is willing to provide written informed consent to participate in the study.
排除标准
- •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.
- •Any diagnosed, acquired, or congenital bleeding or coagulation disorders (e.g., diagnosed thrombophilia, bleeding diatheses).
- •INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists.
- •Last dose of non-vitamin K antagonist oral anticoagulant (NOAC) < 48 hours before the procedure, in patients receiving NOAC therapy.
- •Last dose of low-molecular-weight heparin (LMWH) < 12 hours before the procedure, in patients receiving LMWH therapy.
- •Presence of contraindications to brain magnetic resonance imaging (e.g., claustrophobia, metallic implants/prostheses).
- •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.
研究组 & 干预措施
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.
干预措施: early anticoagulation (Other)
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.
干预措施: late anticoagulation (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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(during 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)
- 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)
- Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography(during index procedure)
- Major adverse cardiac and cerebrovascular events death (all-cause and cardiovascular), stroke, TIA, non-fatal myocardial infarction or peripheral embolization, within 30 days from the index procedure.(within 30 days from index procedure)