Anticoagulation, Atrial Fibrillation, Mitral Regurgitation
Conditions
Brief 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.
Interventions
Anticoagulation prior to transseptal puncture
OTHERlate anticoagulation
Anticoagulation after transseptal puncture
Sponsors
National Institute of Cardiology, Warsaw, Poland
Medical Research Agency, Poland
Soft Communication, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | 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 or left atrium as assessed with periprocedural transsesophageal echocardiography | 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 (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 |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORJerzy Pręgowski, MD, PhD
National Institute of Cardiology
Outcome results
None listed