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A prospective, randomized controlled study of the short - and mid-term efficacy of left atrial appendage closure in minimally invasive cardiac surgery without atrial fibrillation

A prospective, randomized controlled study of the short - and mid-term efficacy of left atrial appendage closure in minimally invasive cardiac surgery without atrial fibrillation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073676
Enrollment
Unknown
Registered
2023-07-18
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Atrial fibrillation after cardiac surgery

Interventions

Left atrial appendage occlusion group:Standard minimally invasive cardiac surgery was performed with concomitant left atrial appendage closure
Control group:Standard minimally invasive cardiac surgery alone

Sponsors

Department of Cardiovascular Surgery, the First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Age =18 and =80 years old; ? planned minimally invasive cardiac surgery; ? no history of atrial fibrillation confirmed by preoperative electrocardiogram; ? high stroke risk CHA2DS2-VASc score =2; ? no evidence of long-term anticoagulation at the time of registration; ? The participants or their legal representatives understood the purpose of the study, were willing to cooperate with the specific follow-up evaluation, voluntarily participated in the study, and signed the written informed consent, which was approved by the ethics committee of the hospital.

Exclusion criteria

Exclusion criteria: ? Traditional median thoracotomy ? Mechanical valve replacement ? Previous history of atrial fibrillation ? Expected survival time < 1 year ? patients with previous LAAO implantation ? combined with other diseases requiring long-term oral anticoagulants ? Ischemic stroke or TIA within the past 30 days ? any major medical condition that the investigator believes may affect the patient's optimal participation in the study.

Design outcomes

Primary

MeasureTime frame
Color Doppler echocardiography;blood routine examination;coagulation function;Blood biochemical indexes;Brain natriuretic peptide;

Countries

China

Contacts

Public ContactXiaoshen Zhang

Department of Cardiovascular Surgery, the First Affiliated Hospital of Jinan University

xszhang@jnu.edu.cn+86 138 0283 0960

Outcome results

None listed

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