Non-Valvular Atrial Fibrillation NVAF
Conditions
Interventions
SAPT arm: Monotherapy with oral anticoagulants (OAC) including direct oral anticoagulants (DOAC) and vitamin K antagonist oral anticoagulants (VKA) for 45 days after left atrial appendage closure (LAA
Sponsors
Yamamoto Masanori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient has documented non-valvular atrial fibrillation (ie, atrial fibrillation without severe mitral stenosis or mechanical valves) 2)Patient has CHA2DS2-VA score of 2 or greater 3)Patient meets the guidelines for proper use of the left atrial appendage closure system, including patient who has an increased risk of bleeding 4)Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak [>3 mm] or major morbidity by the time of procedure completion). 5)Subject is suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms 6)LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure 7)The patient and the investigator and/or subinvestigator agree that the patient will return for all required VISITs after LAAC procedure 8)Patient has thoroughly understood the purpose of the study and who has provided informed written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients who are currently enrolled in other clinical trials, except when the patient is participating in a mandatory governmental registries or purely observational registries with no associated treatment. 2) Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions, previous pulmonary embolism, or deep venous thrombosis). 3) Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction,history of PCI, history of endovascular treatment, history of stroke/transient ischemic attack, significant coronary stenosis proven by myocardial ischemia, severe carotid stenosis requiring invasive treatment,hematologic disease such as antiphospholipid syndrome or if the investigator and/or subinvestigator judged the need for antiplatelet therapy). 4) Patients who meet one or more of the following criteria - Patients who are contraindicated for DOAC or VKA - Patients with a contraindication to aspirin - Patients diagnosed with an allergy to aspirin 5) Those who have or are scheduled to undergo cardiac or noncardiac intervention or surgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, cardiac ablation, other structural heart interventions). 6) Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment 7) Patients with active bleeding 8) Individuals who lack LAA or whose LAA has been surgically ligated 9) Individuals who experienced a myocardial infarction (with or without intervention) recorded as a non-ST elevation myocardial infarction or ST elevation myocardial infarction in the 30-day period prior to enrollment 10) Patients with previous atrial septal repair or with atrial septal defect/patent foramen ovale device 11) Patients with mechanical valve prostheses at any site 12) Persons with known contraindications to TEE 13) Patients with active infection 14) Individuals with NYHA class related IV congestive heart failure at enrollment 15) Patients who are pregnant, breastfeeding, or wishing to become pregnant 16) Patients with an expected life expectancy of less than 2 years 17) Patients requiring emergency surgery for any reason 18) Patients who, at the discretion of the investigator, have other medical, social, or psychological conditions that preclude adherence to appropriate consent or the follow-up tests required by the protocol 19) Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriateudy to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite endpoint consisting of all-cause mortality, myocardial infarction, stroke (ischemic or hemorrhagic), systemic embolism (other than cerebral infarction), major bleeding, or clinically relevant non-fatal bleeding from randomization to the end of study observation(up to a maximum follow-up of 4 years). | — |
Secondary
| Measure | Time frame |
|---|---|
| -The composite endpoint consisting of all cause mortality, myocardial infarction, stroke (ischemic or hemorrhagic), systemic embolism (excluding cerebral infarction), and major bleeding or clinically relevant non fatal bleeding, from 46 days after randomization until the end of the observation period, will be calculated in the same manner as the primary endpoint. - All procedure unrelated BARC bleeding Type 1 or greater from randomization up to the end of study observation (up to 4 years of follow-up). Non-procedure-related was defined as occurring after 7 days after the LAAC procedure. The same will be calculated from 46 days after randomization through the end of study observation. - The incidence rates of the following events from randomization until the end of the observation period (up to 4 years of follow up). The same rates will also be calculated from 46 days after randomization until the end of the study. Procedure unrelated events are defined as those occurring more than 7 days after the procedure. --Incidence rate of procedure unrelated major bleeding and clinically relevant non major bleeding according to the ISTH criteria --Incidence rate of procedure unrelated major bleeding according to the ISTH criteria --Incidence rate of procedure unrelated clinically relevant non major bleeding according to the ISTH criteria -The incidence rates of the following events from randomization until the end of the observation period (up to 4 years of follow up). The same rates will also be calculated from 46 days after randomization until the end of the study. --Incidence rate of procedure unrelated major bleeding or clinically relevant non fatal bleeding (BARC Type 2, 3, or 5) --Incidence rate of procedure unrelated major bleeding (BARC Type 3 and 5 bleeding) --Incidence rate of procedure unrelated clinically relevant non fatal bleeding (BARC Type 2 bleeding) - Incidence of DRTs based on CT and/or TEEs at 45 days, 1 year, and 2 years after randomization. - C | — |
Contacts
Public ContactMasanori Yamamoto
Toyohashi Heart Center
Outcome results
None listed