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Heart pouch plug may cut stroke risk for AFib patients who Can't take blood thinners

NCT ID NCT07396493

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a device called AnchorMan that is placed in the heart to seal a small pouch where clots can form. It is for people with a type of irregular heartbeat (atrial fibrillation) who are at high risk for stroke. The main goal is to see how well the device gets covered by the body's own cells over 6 months, which helps prevent strokes. About 306 participants will be followed for 6 months after the procedure.

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

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 days and older

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: 1. Age ≥ 18 years with non-valvular atrial fibrillation (NVAF). 2. High stroke risk: CHA2DS2-VASc score ≥ 2 (Male) or ≥ 3 (Female) AND meeting any of the following: 1. Documented history of bleeding (\> 6 months ago) or bleeding tendency (e.g., gingival, nasal, GI, urinary tract, cerebral hemorrhage). 2. Intolerance or unwillingness to undergo long-term anticoagulation therapy. 3. Recurrent stroke or embolic events despite standardized anticoagulation. 4. Predicted high bleeding risk (HAS-BLED score ≥ 3). 5. Status post-Left Atrial Appendage Electrical Isolation (LAAEI). 3. Subject or legal representative understands the study purpose, is willing to cooperate with surgery and follow-up, and has signed the written Informed Consent Form (ICF). Exclusion Criteria: 1. Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient \> 40 mmHg). 2. Left ventricular ejection fraction (LVEF) \< 30%. 3. Complex LAA anatomy unsuitable for LAAO implantation. 4. Pericardial effusion \> 10mm. 5. Planned ablation or cardioversion post-procedure. 6. Intracardiac thrombus (including left/right atrium). 7. Myocardial infarction within the last 3 months. 8. History of ASD repair or PFO occluder implantation. 9. History of heart valve replacement (mechanical valve). 10. Heart transplant recipient. 11. New-onset ischemic stroke or TIA within the last 30 days. 12. Severe heart failure (NYHA Class IV). 13. Severe renal impairment: eGFR \< 45 ml/min/1.73m² or on dialysis. 14. Hypersensitivity or contraindication to aspirin, clopidogrel, heparin, contrast media, or nitinol. 15. Pregnant or lactating women, or those planning pregnancy within one year. 16. Life expectancy \< 12 months. 17. Unable to complete 2 months of anticoagulation or 6 months of DAPT for any reason. 18. Investigator's judgment of poor compliance or inability to complete the study requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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