Status:
COMPLETED
WATCHMAN FLX™ CT Study
Lead Sponsor:
Boston Scientific Corporation
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
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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 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
- 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 transient ischemic attack (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.
Key Trial Info
Start Date :
November 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05324371
Start Date
November 9 2022
End Date
January 23 2025
Last Update
July 1 2025
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark