Heart pouch plug may cut stroke risk for AFib patients who Can't take blood thinners
NCT ID NCT07396493
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.
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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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About 306 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 days and older
- 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.
Show the full entry requirements Hide 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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How to take part
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The official record
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