A Pilot Study to Assess WATCHMAN FLX™ Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX™ CT
- Conditions
- The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation
- Registration Number
- NCT05324371
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Subject is of legal age to participate in the study per the laws of their respective<br> geography.<br><br> - Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation<br> in the absence of moderate or greater mitral stenosis or a mechanical heart valve).<br><br> - Subject is clinically indicated for a WATCHMAN FLX device.<br><br> - Subject is deemed suitable for the protocol-defined pharmacologic regimen.<br><br> - Subject or legal representative is able to understand and willing to provide written<br> informed consent to participate in the study.<br><br> - Subject is able and willing to return for required follow-up visits and<br> examinations.<br><br>Exclusion Criteria:<br><br> - Subject is currently enrolled in another investigational study, except if the<br> subject is participating in a mandatory governmental registry, or a purely<br> observational registry with no associated treatment.<br><br> - Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).<br><br> - Subject is contraindicated for TEE.<br><br> - Subject requires long-term anticoagulation therapy for reasons other than AF-related<br> stroke risk reduction (e.g., due to an underlying hypercoagulable state).<br><br> - Subject had or is planning to have any cardiac or non-cardiac intervention or<br> surgical procedure within 30 days prior to or 60 days after implant (including, but<br> not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation,<br> cataract surgery, etc.).<br><br> - Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or<br> transient ischemic attack (TIA) within the 30 days prior to enrollment.<br><br> - Subject had a prior major bleeding event per ISTH definitions within the 30 days<br> prior to enrollment. Lack of resolution of related clinical sequelae or planned and<br> pending interventions to resolve bleeding/bleeding source are a further exclusion<br> regardless of timing of the bleeding event.<br><br> - Subject has an active bleed.<br><br> - Subject has a reversible cause for AF or has transient AF.<br><br> - Subject has no LAA or the LAA is surgically ligated.<br><br> - Subject has had a myocardial infarction (MI) documented in the clinical record as<br> either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or<br> without intervention, within 30 days prior to enrollment.<br><br> - Subject has a history of atrial septal repair or has an atrial septal defect/patent<br> foramen ovale (ASD/PFO) device.<br><br> - Subject has a known contraindication to percutaneous catheterization procedure.<br><br> - Subject has a cardiac tumor.<br><br> - Subject has signs/symptoms of acute or chronic pericarditis.<br><br> - Subject has an active infection.<br><br> - There is evidence of tamponade physiology.<br><br> - Subject has New York Heart Association Class IV congestive heart failure at the time<br> of enrollment.<br><br> - Subject is of childbearing potential and is, or plans to become, pregnant during the<br> time of the study (method of assessment per study physician's discretion).<br><br> - Subject has a documented life expectancy of less than 6 months.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device tissue coverage
- Secondary Outcome Measures
Name Time Method