Non-valvular Atrial Fibrillation (NVAF)AnchorMan-NVAFNCT07396493
A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMan® Left Atrial Appendage Occluder in Non-valvular Atrial Fibrillation Patients at High Risk of Stroke
A study testing Intra-operative application of LAAC in people with Non-valvular Atrial Fibrillation (NVAF) and High Risk of Stroke, run by Shanghai Zhongshan Hospital.
Trial summary
This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data… Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF), High Risk of Stroke
- What is being tested?
- Intra-operative application of LAAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years with non-valvular atrial fibrillation (NVAF).
- High stroke risk: CHA2DS2-VASc score ≥ 2 (Male) or ≥ 3 (Female) AND meeting any of the following:
- Documented history of bleeding (> 6 months ago) or bleeding tendency (e.g., gingival, nasal, GI, urinary tract, cerebral hemorrhage).
- Intolerance or unwillingness to undergo long-term anticoagulation therapy.
- Recurrent stroke or embolic events despite standardized anticoagulation.
- Predicted high bleeding risk (HAS-BLED score ≥ 3).
- Status post-Left Atrial Appendage Electrical Isolation (LAAEI).
- 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).
Who cannot join
- Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient > 40 mmHg).
- Left ventricular ejection fraction (LVEF) < 30%.
- Complex LAA anatomy unsuitable for LAAO implantation.
- Pericardial effusion > 10mm.
- Planned ablation or cardioversion post-procedure.
- Intracardiac thrombus (including left/right atrium).
Show all 18Show fewer
- Myocardial infarction within the last 3 months.
- History of ASD repair or PFO occluder implantation.
- History of heart valve replacement (mechanical valve).
- Heart transplant recipient.
- New-onset ischemic stroke or TIA within the last 30 days.
- Severe heart failure (NYHA Class IV).
- Severe renal impairment: eGFR < 45 ml/min/1.73m² or on dialysis.
- Hypersensitivity or contraindication to aspirin, clopidogrel, heparin, contrast media, or nitinol.
- Pregnant or lactating women, or those planning pregnancy within one year.
- Life expectancy < 12 months.
- Unable to complete 2 months of anticoagulation or 6 months of DAPT for any reason.
- Investigator's judgment of poor compliance or inability to complete the study requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data for clinical application and further product development.
Study Size and Duration: This study plans to enrol1 306 patients. All participants will undergo follow up immediately after occluder implantation, prior to discharge or within 7 days post-procedure, at 1 month post-procedure, at 3 months post-procedure,and at 6 months post-procedure. The total study duration is projected to be 3 year.
The expected duration of participation for each participant is approximately 6 months.
Read the detailed description
Endothelialization within the left atrial appendage represents a core biological process following transcatheter left atrial appendage closure (LAAC). Advances in this field directly influence the optimization of postoperative anticoagulation strategies and the control of device related thrombosis (DRT) risks.
This multicenter, prospective, single-arm study primarily investigates the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occlusion Device using cardiac CTA following left atrial appendage occlusion. It plans to enroll 306 non-valvular atrial fibrillation patients undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.
The device used in this study is the approved AnchorMane® Left Atrial Appendage Occlusion System, which is routinely employed in clinical practice.
What is required of me if I participate in the study?
If you decide to participate in this study, you will be enrolled after signing the informed consent form with full understanding. Participation in this trial requires your cooperation with the study physician to complete the following examinations or procedures :
- Baseline Visit (within 7 days pre-op): Collection of routine medical history, demographic data, physical examination,vital signs, modified Rankin Scale (mRS) score (if applicable), CHA2DS2,-VASc score.HAS-BLED score, NYHA functional class, electrocardiogram (EcG), laboratory tests(complete blood count, urinalysis, blood chemistry, coagulation profile, blood/urine pregnancy testif indicated, serum inflammatory markers),transesophageal echocardiography(TEE), and transthoracic echocardiography (TTE).
- Baseline Visit (Intra-operative): Vital signs, serum inflammatory markers, left atrial angiography, surgical records, medication records. Collect and document endpoint events and other adverse events.
- Discharge/Post-op 7-day Visit: Collect vital signs, modified Rankin Scale (mRS)score (if applicable), NYHA functional class, transthoracic echocardiogram (TTE), and laboratory test results (complete blood count, urinalysis, blood biochemistry, coagulation function, serum inflammatory markers)Complete medication records and collect/record for routine clinical care.information on endpoint events and other adverse events.
- 1-month Follow-up (±7 days): Collect results from routine diagnostic procedures including cardiac ultrasound (if applicable), cardiac CTA (if applicable), and laboratory tests.Complete documentation of medication history, endpoint events, and other adverse event information.
- 3-month Follow-up (±15 days): Complete and collect your routine clinical vital signs, cardiac ultrasound (if applicable), cardiac CTA, and serum inflammatory marker test results.Complete medication records, endpoint event documentation, and other adverse event records.
- 6-month Follow-up (±30 days): Complete and collect results of routine clinical examinations including vital signs, cardiac ultrasound, cardiac CTA, and serum inflammatory markers. Complete medication records, endpoint event documentation, and other adverse event records.
- Note: Laboratory tests included in the study comprise: Complete blood count : Collect hemoglobin, red blood cell, white blood cell, and platelet counts; Urinalysis: Collect urine red blood cells, urine white blood cells, urine protein, and urine glucose levels. Blood Biochemistry: Preoperative testing for total cholesterol, triglycerides,LDL cholesterol, HDl cholesterol, Creatinine, BUN, fasting blood glucose, albumin, ALT,AST; Pre-discharge Creatinine, alanine aminotransferase (ALT)，aspartatetests: aminotransferase (AsT). Coagulation function tests: Prothrombin time (PT), Prothrombintime international normalized ratio (INR), Activated partial thromboplastin time (APTT),Thrombin time (TT). Approximately 3 ml of blood will be drawn for each blood test, and approximately 3 ml of urine will be collected for each urine test. Your blood and urine samples will be used solely for routine hospital analysis and will not be sent externally.Remaining samples will be destroyed according to standard hospital protocols. During the study, we will need to collect your imaging data. This data will undergo de-identification and will be used exclusively for this research.
- Being tested
- Intra-operative application of LAAC
- Keywords
- Non-valvular atrial fibrillation (NVAF), high risk of stroke., Left Atrial Appendage Occluder System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative application of LAACProcedure or surgery
Undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | AnchorMan® Left Atrial Appendage Occluder System Treatment Receives: Procedure: Intra-operative application of LAAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete endothelialization rate of the LAA occluder
The proportion of subjects whose cardiac CTA shows complete endothelialization of the LAAO at 6 months post-occlusion. Complete endothelialization is defined as LAA density < 100 HU or < 25% of left atrial (LA) density under cardiac CTA examination.
Measured: 6 months post-procedure.
Secondary outcomes (13)
Device success rate
The proportion of subjects who correctly deployed and implanted the device in the appropriate location
Measured: immediate post-procedure
Clinical success rate
The proportion of patients who do not experience ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death, or death of unknown cause after occlusion.
Measured: 6 months post-operation
Procedural success rate
Successful left atrial appendage occlusion with no device-related complications at discharge or within 7 days post-operation (whichever comes first).
Measured: 7 days post-operation or at discharge
Incidence of stroke and transient ischemic attack (TIA)
Stroke is defined as all strokes in the Valve Research Consortium (VARC-3), specifically including ischemic stroke, hemorrhagic stroke, and undetermined stroke.
Measured: 3 months post-operation, 6 months post-operation
Incidence of systemic embolism
Embolism other than stroke, such as myocardial infarction, pulmonary embolism, renal infarction, splenic infarction, limb ischemia, mesenteric ischemia, etc.
Measured: 3 months post-operation, 6 months post-operation
Serious bleeding events
Serious bleeding refers to bleeding events of types 3-5 as defined in the Bleeding Research Consortium (BARC)
Measured: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
All-cause mortality
Refer to the definition in VARC-3, which refers to death from any cause, including cardiovascular and non-cardiovascular death.
Measured: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
Incidence of Device-Related Complications
Device-related complications include device embolism, device corrosion, clinically significant device-to-surrounding structure interference, device thrombosis, device breakage, device infection/endocarditis/pericarditis, device perforation/tear, device allergy-induced cardiac tamponade, pericardial effusion requiring intervention, occluder embolism, and cardiac perforation.
Measured: 6 Months Post-Op
Occluder Performance
Cardiac CTA or transesophageal (or chest wall) echocardiography was used to evaluate the device, including displacement, dislodgement, mitral regurgitation, residual shunt, and device-related thrombosis. The incidence of these events was calculated.
Measured: 6 Months Post-Op
Left atrial appendage occluder complete endothelialization rate
The proportion of subjects whose cardiac CTA shows complete endothelialization of the LAAO at 3 months post-occlusion. Complete endothelialization is defined as LAA density < 100 HU or < 25% of left atrial (LA) density under cardiac CTA examination.
Measured: 3 months post-operation
Device-related thrombosis (DRT) incidence
assessed using cardiac CTA. DRT appears as a low-density filling defect on the left atrial side of the device surface. A thicker (>3 mm) and more prominent low-density defect is considered a typical manifestation of DRT.
Measured: 3 months post-operation, 6 months post-operation
Residual Leak (PDL) Incidence
Cardiac CTA was used for assessment. A residual left atrial appendage density ≥100 HU or ≥25% of the left atrial density indicated the presence of a PDL. If TEE was used for assessment, residual shunts were classified based on color jet width as: minimal (1 mm), mild (1-3 mm), or relatively significant (3 mm). Complete closure was defined as no residual shunt greater than 5 mm on TEE examination.
Measured: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE includes perioperative complications and long-term follow-up complications. Specifically:
- Perioperative complications: death, cardiac tamponade, device embolism, stroke, severe bleeding, and vascular access complications;
- Long-term follow-up complications: ischemic stroke, hemorrhagic stroke, thromboembolism, device-related thrombosis, severe bleeding, and death.
Measured: 3 months post-operation, 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start8 Feb 2026 (estimated)
- Primary completion12 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhoupu Hospital, Pudong New Area, Shanghai, China, Changhai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396493
- Sponsor's protocol ID
- AM-PM-02
- Other IDs
- 25SF1902201
- Acronym
- AnchorMan-NVAF
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMan® Left Atrial Appendage Occluder in Non-valvular Atrial Fibrillation Patients at High Risk of Stroke
- ClinicalTrials.gov ID
- NCT07396493
- Acronym / sponsor ID
- AnchorMan-NVAF / AM-PM-02
- Keywords
- Non-valvular atrial fibrillation (NVAF), high risk of stroke., Left Atrial Appendage Occluder System
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhoupu Hospital, Pudong New Area, Shanghai, China, Changhai Hospital
- Study start
- 8 Feb 2026 (estimated)
- Primary completion
- 12 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data for clinical application and further product development.
Study Size and Duration: This study plans to enrol1 306 patients. All participants will undergo follow up immediately after occluder implantation, prior to discharge or within 7 days post-procedure, at 1 month post-procedure, at 3 months post-procedure,and at 6 months post-procedure. The total study duration is projected to be 3 year.
The expected duration of participation for each participant is approximately 6 months.
Detailed description
Endothelialization within the left atrial appendage represents a core biological process following transcatheter left atrial appendage closure (LAAC). Advances in this field directly influence the optimization of postoperative anticoagulation strategies and the control of device related thrombosis (DRT) risks.
This multicenter, prospective, single-arm study primarily investigates the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occlusion Device using cardiac CTA following left atrial appendage occlusion. It plans to enroll 306 non-valvular atrial fibrillation patients undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.
The device used in this study is the approved AnchorMane® Left Atrial Appendage Occlusion System, which is routinely employed in clinical practice.
What is required of me if I participate in the study?
If you decide to participate in this study, you will be enrolled after signing the informed consent form with full understanding. Participation in this trial requires your cooperation with the study physician to complete the following examinations or procedures :
- Baseline Visit (within 7 days pre-op): Collection of routine medical history, demographic data, physical examination,vital signs, modified Rankin Scale (mRS) score (if applicable), CHA2DS2,-VASc score.HAS-BLED score, NYHA functional class, electrocardiogram (EcG), laboratory tests(complete blood count, urinalysis, blood chemistry, coagulation profile, blood/urine pregnancy testif indicated, serum inflammatory markers),transesophageal echocardiography(TEE), and transthoracic echocardiography (TTE).
- Baseline Visit (Intra-operative): Vital signs, serum inflammatory markers, left atrial angiography, surgical records, medication records. Collect and document endpoint events and other adverse events.
- Discharge/Post-op 7-day Visit: Collect vital signs, modified Rankin Scale (mRS)score (if applicable), NYHA functional class, transthoracic echocardiogram (TTE), and laboratory test results (complete blood count, urinalysis, blood biochemistry, coagulation function, serum inflammatory markers)Complete medication records and collect/record for routine clinical care.information on endpoint events and other adverse events.
- 1-month Follow-up (±7 days): Collect results from routine diagnostic procedures including cardiac ultrasound (if applicable), cardiac CTA (if applicable), and laboratory tests.Complete documentation of medication history, endpoint events, and other adverse event information.
- 3-month Follow-up (±15 days): Complete and collect your routine clinical vital signs, cardiac ultrasound (if applicable), cardiac CTA, and serum inflammatory marker test results.Complete medication records, endpoint event documentation, and other adverse event records.
- 6-month Follow-up (±30 days): Complete and collect results of routine clinical examinations including vital signs, cardiac ultrasound, cardiac CTA, and serum inflammatory markers. Complete medication records, endpoint event documentation, and other adverse event records.
- Note: Laboratory tests included in the study comprise: Complete blood count : Collect hemoglobin, red blood cell, white blood cell, and platelet counts; Urinalysis: Collect urine red blood cells, urine white blood cells, urine protein, and urine glucose levels. Blood Biochemistry: Preoperative testing for total cholesterol, triglycerides,LDL cholesterol, HDl cholesterol, Creatinine, BUN, fasting blood glucose, albumin, ALT,AST; Pre-discharge Creatinine, alanine aminotransferase (ALT)，aspartatetests: aminotransferase (AsT). Coagulation function tests: Prothrombin time (PT), Prothrombintime international normalized ratio (INR), Activated partial thromboplastin time (APTT),Thrombin time (TT). Approximately 3 ml of blood will be drawn for each blood test, and approximately 3 ml of urine will be collected for each urine test. Your blood and urine samples will be used solely for routine hospital analysis and will not be sent externally.Remaining samples will be destroyed according to standard hospital protocols. During the study, we will need to collect your imaging data. This data will undergo de-identification and will be used exclusively for this research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Intra-operative application of LAACAnchorMan® Left Atrial Appendage Occluder System Treatment |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years with non-valvular atrial fibrillation (NVAF).
- High stroke risk: CHA2DS2-VASc score ≥ 2 (Male) or ≥ 3 (Female) AND meeting any of the following:
- 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).
Key exclusion criteria (18 listed)
- Rheumatic heart disease, moderate-to-severe mitral stenosis/regurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient > 40 mmHg).
- Left ventricular ejection fraction (LVEF) < 30%.
- Complex LAA anatomy unsuitable for LAAO implantation.
- Pericardial effusion > 10mm.
- Planned ablation or cardioversion post-procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-operative application of LAACUndergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation. | Procedure or surgery | Treatment Group |
Primary outcome
Complete endothelialization rate of the LAA occluder
Time frame: 6 months post-procedure.
The proportion of subjects whose cardiac CTA shows complete endothelialization of the LAAO at 6 months post-occlusion. Complete endothelialization is defined as LAA density < 100 HU or < 25% of left atrial (LA) density under cardiac CTA examination.
13 secondary outcomes
Device success rate
Time frame: immediate post-procedure
Clinical success rate
Time frame: 6 months post-operation
Procedural success rate
Time frame: 7 days post-operation or at discharge
Incidence of stroke and transient ischemic attack (TIA)
Time frame: 3 months post-operation, 6 months post-operation
Incidence of systemic embolism
Time frame: 3 months post-operation, 6 months post-operation
Serious bleeding events
Time frame: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
All-cause mortality
Time frame: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
Incidence of Device-Related Complications
Time frame: 6 Months Post-Op
Occluder Performance
Time frame: 6 Months Post-Op
Left atrial appendage occluder complete endothelialization rate
Time frame: 3 months post-operation
Device-related thrombosis (DRT) incidence
Time frame: 3 months post-operation, 6 months post-operation
Residual Leak (PDL) Incidence
Time frame: before discharge or 7 days post-operation, 3 months post-operation, 6 months post-operation
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 3 months post-operation, 6 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative application of LAAC in people with Non-valvular Atrial Fibrillation (NVAF) and High Risk of Stroke, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wenzhi pan (0755-1234567, peden@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete endothelialization rate of the LAA occluder (time frame: 6 months post-procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.