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Post market clinical study on the safety and effectiveness of left atrial appendage occluder system (trade name: LACbes) in 'real world' patients with nonvalvular atrial fibrillation

Post market clinical study on the safety and effectiveness of left atrial appendage occluder system (trade name: LACbes) in 'real world' patients with nonvalvular atrial fibrillation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053615
Enrollment
Unknown
Registered
2021-11-25
Start date
2022-01-11
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of stroke with atrial fibrillation

Interventions

case series:None

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 85 years (not include 85 years old); 2.Patients with non valvular atrial fibrillation who meet the LAAC treatment indications (CHADS2 score >= 1 and are not suitable for long-term use of warfarin anticoagulants); 3.The expected service life shall not be less than 1 year; 4.Patients who can understand the purpose of this study, voluntarily participate in and sign informed consent, have good compliance after discharge and are willing to accept clinical follow-up; 5.Tolerance of materials or drugs related to this study.

Exclusion criteria

Exclusion criteria: 1.Thrombus or suspected thrombus in left atrium or left atrial appendage was detected by transesophageal echocardiography (TEE) or cardiac CT imaging (CCTA) before operation; 2.Left ventricular ejection fraction (LVEF) 200 µmol/L; 5.TTE examination showed that there was pericardial effusion more than 10 mm in the bottom or posterior wall of the heart; 6.Patients with severe heart valve disease or cardiac structural abnormalities (such as huge atrial septal defect and ventricular septal defect) requiring surgical treatment, or patients with severe coronary heart disease requiring coronary artery bypass grafting; 7.Active bleeding, severe abnormal coagulation function (1.5 times higher than the upper limit of normal value) or platelet count < 80 x 10^9/L; 8.Pregnant or lactating women; 9.Patients who participated in other clinical trials within 1 month before enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of major clinical events;

Secondary

MeasureTime frame
Incidence of bleeding events;Incidence of cardioascular death;Immediate surgical success rate;Incidence of device related complications;Incidence of all-cause deaths;

Countries

China

Contacts

Public ContactZhou Daxin

Zhongshan Hospital Affiliated to Fudan University

liluo418@163.com+86 13801641252

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026