Watchman FLX Pro CT Pilot Study

Study Overview
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Brief Summary
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The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) and assess its relationship, if any, to clinical events.

Detailed Description
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WATCHMAN FLX™ Pro CT is a prospective, single-arm, single-center, premarket investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX Pro device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used. A core laboratory will independently assess select results. A subject is considered enrolled in the study when the subject or the subject's legally authorized representative signs an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC). Up to 50 subjects in whom placement of a WATCHMAN FLX Pro device is attempted will be enrolled. A baseline assessment including TEE and/or CT imaging with optional cardiac magnetic resonance imaging (MRI) will be done within 7 days prior to the index procedure following core laboratory guidelines. Follow-up clinical assessment and imaging will occur at 14 days, 45 days, and 3 months post index procedure; only clinical assessment will be required at 12 months (unless an in-person assessment is required based on other data). Subjects who are enrolled but not implanted with a WATCHMAN FLX Pro LAAC device will be followed for safety through 12 months after the initial attempted index procedure but will not undergo imaging assessments or evaluation of biochemical markers including measures of coagulation, platelet and endothelial activation and inflammation.

Official Title
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A Pilot Study to Assess WATCHMAN FLX™ Pro Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX Pro CT

Conditions
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Non-valvular Atrial Fibrillation (AF)

Intervention / Treatment
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* Device: Left atrial appendage closure device WM FLX Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is of legal age to participate in the study per the laws of their respective geography. Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). Subject is clinically indicated for a WATCHMAN FLX Pro device. Subject is deemed suitable for the protocol-defined pharmacologic regimen. Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study. Subject is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: Exclusion criteria are listed below. Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V). Subject is contraindicated for TEE. Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state). Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.). Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or TIA within the 30 days prior to enrollment. Subject had a prior major bleeding event per ISTH definitions within the 30 days prior to enrollment. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event. Subject has an active bleed. Subject has a reversible cause for AF or has transient AF. Subject has no LAA or the LAA is surgically ligated. Subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment. Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device. Subject has a known contraindication to percutaneous catheterization procedure. Subject has a cardiac tumor. Subject has signs/symptoms of acute or chronic pericarditis. Subject has an active infection. There is evidence of tamponade physiology. Subject has New York Heart Association Class IV congestive heart failure at the time of enrollment. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion). Subject has a documented life expectancy of less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Watchman FLX Pro<br> | Device: Left atrial appendage closure device WM FLX Pro<br>* Left atrial appendage closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Tissue Coverage | Device surface morphology (inclusive of tissue coverage) post implant procedure as assessed over time using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) with data evaluated by an independent core laboratory. | 45 days post-implant |