Mitral regurgitation Atrial fibrilation Periprocedural anticoagulation strategy in patients treated with MitraClip implantation or Left Atrial Appendage Closure. The patients scheduled for MitraClip or LAAC procedure will be randomized to initiation of the unfractionated heparin either 15 minutes before or immediately after transseptal puncture. MedDRA version: 20.0 Level: LLT Classification code 10027718 Term: Mitral regurgitation System Organ Class: 10007541 - Cardiac disorders MedDRA ve
Conditions
Interventions
Trade Name: heparin sodium
Product Name: HEPARIN SODIUM
Pharmaceutical Form: Anticoagulant and preservative solution for blood
INN or Proposed INN: Heparin
CAS Number: 9005-49-6
Other descriptive name
Sponsors
National Institute of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age above 18 years 2.Planned treatment of mitral regurgitation with MitraClip implantation or planned left atrial appendage closure with Watchman Left Atrial Appendage Closure Device (Boston Scientific) or Amplatze LAA ocluder (Abbott) 3.The patient is willing to comply will all study procedures 4.The patient is willing to sign informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 164 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 246
Exclusion criteria
Exclusion criteria: 1.Pregnant or breast feeding women or women with childbearing potential who do not agree to use at least two contraceptive measures (oral contraconception, mechanical contraconception, approved contraceptive implant, intrauterine device, tubal ligation) The criterion does not apply to postmenopausal women (defined as at least one year of no menstrual periods) at least 2 years prior to the enrollment or women who underwent surgical sterilization procedure. Otherwise female younger that 55 years must have negative pregnancy test within 24 hours prior to randomization. 2.Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis) 3.INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. 4.Last dose of new oral anticoagulant < 48 hours prior to the procedure. 5.Last dose of low molecular weight heparin <12 hours prior to the procedure. 6.Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic metalic prostheses) 7. Implanted cardiac devices for electrotherapy if: - device or leads are labeled as MR unsafe - the patient has implanted CRT or device with epicardial leads - left disconnected electrodes or non-functional or damaged devices including those within abdominal wall - the patient is pacemaker dependant - the device was implanted or exchanged within 6 weeks prior to the MR examination - device mulfunction identified during the control performed immediately prior to the MR examination - low voltage of the device battery - the battery on the examination day should have at least 30% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to compare efficacy and safety of two strategies of initiation of anticoagulation with unfractionated heparin (UFH) in patients undergoing structural heart interventions requiring transseptal puncture (MitraClip implantation or Left Atrial Appendage Closure). Patients will be randomized to: Early UFH administration. The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 15 minutes prior to the start of the transseptal puncture. or Late UFH administration. The iv. bolus of UFH (100Units/kg) will be given immediately after transseptal puncture, defined as the introduction of the transseptal sheath into the left atrium. ;Secondary Objective: Not applicable;Primary end point(s): Primary composite study endpoint 1. MACCE (death, stroke, TIA, myocardial infaction or peripheral embolization) within 30 days after procedure 2. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with peroprocedural transsesophageal echocardiography 3.Occurence of new ischemic lesions with diameter =4 mm in brain MR performed 2-5 days after procedure The compontents of primary study endpoint will be assessed hierarchically as follow 1. MACCE, 2. intraprocedural thrombus formation 3. new ischemic lesions with diameter =4 mm in brain MR ;Timepoint(s) of evaluation of this end point: MACCE component of primary study endpoint will be assessed within 30 days post index procedure. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with peroprocedural transsesophageal echocardiography will be assess during MitraClip or LAAC procedures. Occurence of new ischemic lesions with diameter =4 mm in brain MR performed 2-5 days after procedure will be assessed within 2-5 days post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study endpoints Secondary safety endpoint: Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization Secondary efficacy endpoints 1. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with peroprocedural transsesophageal echocardiography 2. Occurence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure. 3. Major adverse cardiac and cerebrovascular events (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index procedure. Exploratory study endpoints 1. Number of new ischemic brain lesions in MR examination performed within 2-5 days post index procedure 2. Number of new ischemic brain lesions in MR examination performed within 30-35 days post index procedure 3. Total volume of new ischemic brain lesions in the MR examination performed within 2-5 days post index procedure. 4. Total volume of new ischemic brain lesions in the MR examination performed within 30-35 days post index procedure. 5. Occurence and magnitude of new cognitive changes assessed 2-5 days after index procedure according to Addenbrooke Cognitive Examination III 6. Occurence and magnitude of new cognitive changes assessed 30-35 days after index procedure according to Addenbrooke Cognitive Examination III 7. The changes in the plasma concentration of the biomarker of brain injury - S100B protein 8. The changes in the plasma concentration of the biomarker of brain injury - NSE protein ;Timepoint(s) of evaluation of this end point: 1.Bleeding complications - during the index hospitalization 2.MACCE within 30 days from the index procedure. 3.Occurence, number, total volume of new ischemic brain lesion in the MR examination - within 2-5 days and within 30-35 days post index procedure. 4.Intraprocedural fresh thrombus formation in the right or left atrium as assessed wit | — |
Countries
Poland
Contacts
Public ContactClinical Research Support Center
National Institute of Cardiology
Outcome results
None listed