Watchman FLX Pro CT Pilot Study (NCT05567172) | Clinical Trial Compass
CompletedNot Applicable
Watchman FLX Pro CT Pilot Study
Denmark43 participantsStarted 2023-03-24
Plain-language summary
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLXâ„¢ 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 (…
What they're measuring
1
Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device