Publication context February 20, 2026. A new prospective single arm study maps the endothelialization effect and timeline of the AnchorMan Left Atrial Appendage Occluder in patients with non valvular atrial fibrillation who face high stroke risk. The trial is designed to assess end points related to tissue growth over time after intraoperative implantation of the device and to provide data on safety and performance in a real world setting. Sponsors include Shanghai Zhongshan Hospital Ruijin Hospital Xinhua Hospital of Shanghai Jiao Tong University School of Medicine Zhoupu Hospital in the Pudong New Area Shanghai China and Changhai Hospital. The record is listed on ClinicalTrials.gov under NCT07396493; the status is Not yet recruiting. The focus on endothelialization aims to inform future regulatory and clinical use of the AnchorMan LAAC device.
In this article
- What is the focus of the trial and who is it for?
- What is the study design and recruitment status?
- What is the intervention and what endpoints will be observed?
- Who sponsors the trial and where is it conducted?
- What is the regulatory context for this device study?
- Frequently asked questions
What is the focus of this trial and who is it for?
What is being studied?
The study is a prospective single arm trial that seeks to map the endothelialization process after AnchorMan Left Atrial Appendage Occluder deployment in non valvular atrial fibrillation patients who are at high risk of stroke.
Why it matters for patients and regulators?
Endothelialization data may inform the safety and performance assessment of this device in a real world setting and support informed decision making by clinicians and regulators.
What is the study design and recruitment status?
Study design
The trial uses a prospective design with a single arm and non randomized allocation. Its primary focus is the endothelialization timeline and safety signals related to intraoperative use of AnchorMan LAAC.
Enrollment status
According to the ClinicalTrials.gov record the study is Not yet recruiting.
What is the intervention and what endpoints will be observed?
Intervention details
The intervention involves intraoperative application of the AnchorMan Left Atrial Appendage Occluder in non valvular atrial fibrillation patients eligible for LAAC as part of the trial protocol.
Endpoints and timeline
The primary endpoint concerns the endothelialization effect and the timeline over which tissue coverage develops. The record notes a regulatory and safety focus but does not provide results at this stage.
Who sponsors the trial and where is it conducted?
Sponsoring institutions
Shanghai Zhongshan Hospital Ruijin Hospital Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine Zhoupu Hospital in the Pudong New Area Shanghai China and Changhai Hospital are listed as sponsors.
Geographic locations
Sites are located in Shanghai China.
What is the regulatory context for this device study?
MDR style considerations
The trial presents a data gathering effort focused on device safety performance and endothelialization. Findings would inform risk observations and potential regulatory considerations for the AnchorMan LAAC device with this indication.
Impact on safety and performance claims
Data generated through this study may support future safety and performance claims for the device if results are favorable and robust, under appropriate regulatory review.
- Q1 What is the focus of the trial The trial focuses on the endothelialization effect and timeline of the AnchorMan Left Atrial Appendage Occluder in non valvular atrial fibrillation patients at high stroke risk.
- Q2 Who sponsors the trial and where is it conducted The trial is sponsored by Shanghai based hospitals including Shanghai Zhongshan Hospital Ruijin Hospital Xinhua Hospital of Shanghai Jiao Tong University School of Medicine Zhoupu Hospital in Pudong New Area Shanghai and Changhai Hospital located in Shanghai China.
- Q3 What is the recruitment status The record describes the trial as not yet recruiting.
- Q4 Where can I find more information The ClinicalTrials.gov entry is at https://clinicaltrials.gov/study/NCT07396493?term=medical+device.
Conclusion and implications
This study outlines a regulatory minded inquiry into how the AnchorMan LAAC device migrates to tissue coverage over time in a high risk population. While no results are reported yet this approach signals attention to endothelialization as part of device assessment in non valvular atrial fibrillation care. Clinicians and regulators may watch for updates as recruitment progresses and data accumulate.
Disclaimer
This article is for professional use and does not provide legal advice. It reflects the information in the ClinicalTrials.gov record and related materials. Readers should consult official regulatory documents for binding determinations.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07396493?term=medical+device