A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Usi… (NCT03033134) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
Japan54 participantsStarted 2017-02-27
Plain-language summary
The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. The subject is Japanese, over 20 years old and provides written informed consent to participate in the trial
✓. The subject has documented paroxysmal, persistent or permanent non-valvular atrial fibrillation
✓. The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for long-term oral anti-coagulation therapy
✓. The subject is deemed by their physicians to be suitable for anticoagulant therapy and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin
✓. The subject is eligible to come off warfarin therapy if the LAA (left atrial appendage) is sealed (i.e. the subject has no other conditions that would require warfarin therapy).
Exclusion criteria
✕. The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack within the 90 days prior to consent
✕. The subject has had a myocardial infarction either non-ST elevation or ST elevation myocardial infarction within 90 days prior to consent with or without intervention
✕. The subject had or is planning to have any cardiac (e.g. cardioversion, coronary angiogram, percutaneous coronary intervention, cardiac ablation, etc.) or non-cardiac invasive or surgical procedure (e.g. cataract surgery, endoscopy, etc.) within 30 days prior or 45 days after the BSJ003W implant
✕. The subject has a history of atrial septal repair or has an atrial septal defect/persistent foramen ovale device
✕
What they're measuring
1
Number of Participants With Complications; One of the Following Events
Timeframe: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later
2
Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)
Timeframe: 24-month
3
The Rate of Effective Left Atrial Appendage (LAA) Closure