Heart device healing checked with advanced scans
NCT ID NCT05567172
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how tissue covers the WATCHMAN FLX Pro device after it is placed in the heart to prevent strokes in people with atrial fibrillation. 43 participants received the implant and had follow-up CT scans and echocardiograms to check for any thickening on the device surface. The goal was to see if these imaging findings relate to any health events.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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43 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus University Hospital
Aarhus, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.