Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study

Shanghai 10th People's Hospital0 sites66 target enrollmentApril 14, 2014

ConditionsAtrial Fibrillation Left Atrial Appendage Closure Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Shanghai 10th People's Hospital
Enrollment: 66
Primary Endpoint: Ischemic stroke
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.

Detailed Description

The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.

Registry

clinicaltrials.gov

Start Date

April 14, 2014

End Date

May 1, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai 10th People's Hospital

Responsible Party

Principal Investigator

Ya-Wei Xu

Director, Head of Cardiology, Principal Investigator

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

•Patient is ≥18 years of age;
•Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
•CHADS2-VAS score 2 or higher;
•Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
•Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Exclusion Criteria

•A. Clinical exclusion criteria
•Presence of rheumatic, degenerative or congenital valvular heart diseases,
•The diameter of left atrial ≥65 mm;
•LAA size \< 12mm or \> 30 mm
•Left atrium has been removed;
•Heart transplantation patients;
•Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
•Acute myocardial infarction or unstable angina;
•Decompensated heart failure (New York Heart Association functional class III-IV);
•Recent myocardial infarction (\< 3 months);