A Pilot Study to Assess WATCHMAN FLX™ Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX™ CT
Study Details
Study Description
Brief Summary
WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Device Arm WATCHMAN FLX™ device implantation |
Device: Watchman FLX Device
Left atrial appendage closure using the Watchman FLX device
|
Outcome Measures
Primary Outcome Measures
- Rate of Device Leaks [45 days post-implant]
Significant leak (>5 mm) as assessed by TEE at 45 days post-implant
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is of legal age to participate in the study per the laws of their respective geography.
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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).
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Subject is clinically indicated for a WATCHMAN FLX device.
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Subject is deemed suitable for the protocol-defined pharmacologic regimen.
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Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
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Subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
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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.
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Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
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Subject is contraindicated for TEE.
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Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state).
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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.).
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Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment.
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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.
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Subject has an active bleed.
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Subject has a reversible cause for AF or has transient AF.
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Subject has no LAA or the LAA is surgically ligated.
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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.
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Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device.
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Subject has a known contraindication to percutaneous catheterization procedure.
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Subject has a cardiac tumor.
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Subject has signs/symptoms of acute or chronic pericarditis.
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Subject has an active infection.
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There is evidence of tamponade physiology.
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Subject has New York Heart Association Class IV congestive heart failure at the time of enrollment.
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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).
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Subject has a documented life expectancy of less than 6 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Jens Erik Nielsen-Kudsk, MD, Aarhus University Hospital Skejby
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S2423