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Compares treatment options for Nonvalvular Atrial Fibrillation
Official title Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
ClinicalTrials.gov ID: NCT07125417
What this study is testing
What is Single Antiplatelet Therapy or No Therapy (Control)?
Single Antiplatelet Therapy or No Therapy (Control) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nonvalvular atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet Therapy (SAPT) with aspirin during the period from randomization to the end of observational period (4 years at the maximum) in non-valvular atrial fibrillation subjects with high bleeding risk. The primary endpoint is a composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillation without severe mitral stenosis or mechanical valves)
- Patient has CHA2DS2-VA score of 2 or greater
- Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding.
- Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak [\>3 mm] or...
- Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms
You likely can't join if
- Patients who are currently enrolled in other clinical trials, except when the patient is participating in a mandatory governmental registries or...
- Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction...
- Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment...
- Patients who meet one or more of the following criteria
- Patients who are contraindicated for DOAC or VKA
- Patients with a contraindication to aspirin
See the full eligibility criteria
- Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillation without severe mitral stenosis or mechanical valves)
- Patient has CHA2DS2-VA score of 2 or greater
- Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding.
- 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).
- Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms
- LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure
- The patient and the investigator and/or subinvestigator agree that the patient will return for all required VISITs after LAAC procedure
- Patient has thoroughly understood the purpose of the study and has provided written informed consent to participate in the study
- 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.
- 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).
- Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, history of stroke/transient ischemic attack, significant coronary...
- 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
- 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, PCI, cardiac ablation, cataract surgery, other structural heart...
- Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment
- Patients with active bleeding
- Individuals who lack LAA or whose LAA has been surgically ligated
- 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
- Patients with previous atrial septal repair or with atrial septal defect/patent foramen ovale device
- Patients with mechanical valve prostheses at any site
- Persons with known contraindications to TEE
- Patients with active infection
- Individuals with NYHA class related IV congestive heart failure at enrollment
- Patients who are pregnant, breastfeeding, or wishing to become pregnant
- Patients with an expected life expectancy of less than 2 years
- Patients requiring emergency surgery for any reason
- 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
- Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriate
The study team makes the final eligibility decision.
Where it's taking place
- Nagoya, Aichi-ken, Japan
- Toyohashi, Aichi-ken, Japan
- Matsudo, Chiba, Japan
- Kitakyushu, Fukuoka, Japan
- Gifu, Gifu, Japan
- Sapporo, Hokkaido, Japan
- Isehara, Kanagawa, Japan
- Kawasaki, Kanagawa, Japan
- Sendai, Miyagi, Japan
- Kurashiki, Okayama-ken, Japan
- Okayama, Okayama-ken, Japan
- Ōsaka-sayama, Osaka, Japan
- Bunkyo-ku, Tokyo, Japan
- Chiyoda-ku, Tokyo, Japan
- Fuchū, Tokyo, Japan
- Itabashi-ku, Tokyo, Japan
- Katsushika-ku, Tokyo, Japan
- Ōta-ku, Tokyo, Japan
- Shinjuku-ku, Tokyo, Japan
- Toyama, Toyama, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagoya, Aichi-ken, Japan; Toyohashi, Aichi-ken, Japan; Matsudo, Chiba, Japan; Kitakyushu, Fukuoka, Japan; Gifu, Gifu, Japan; Sapporo, Hokkaido, Japan and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.