Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

NCT ID: NCT03987945

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Left Atrial Appendage Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Left atrial appendage occlusion

Patients with non-valvular atrial fibrillation who have received left atrial appendage occlusion procedure.

left atrial appendage occlusion devices

Intervention Type DEVICE

All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

left atrial appendage occlusion devices

All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital;
* Adult patients (\>18 years old).

Exclusion Criteria

* Patients with rheumatic valvular disease;
* Patients with sick sinus syndrome;
* Patients who had a history of cardiac surgery (i.e., CABG);
* patients who had received the catheter radiofrequency ablation procedure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ya-Wei Xu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yawei Xu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Shanghai Tenth People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mengmeng Gong, M.D.

Role: CONTACT

+86-188-0179-0469

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mengmeng Gong, M.D.

Role: primary

+86-188-0179-0469

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LAAO-SH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.