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Heart device healing checked with advanced scans

NCT ID NCT05567172

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

43 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2025

Lead sponsor

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

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Aarhus University Hospital

    Aarhus, Denmark

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