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Clinical Trials/NCT04376606
NCT04376606
Completed
Not Applicable

Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation

Ruiqin xie1 site in 1 country105 target enrollmentFebruary 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Ruiqin xie
Enrollment
105
Locations
1
Primary Endpoint
Left atrial function of postoperative left atrial appendage occlusion detected
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

A total of 105 (AF) patients with atrial fibrillation are scheduled to undergo surgery and will be divided into three groups. Left atrial appendage occlusion ((LAAC)), radiofrequency ablation guided by three-dimensional mapping and LAAC combined with radiofrequency ablation were performed respectively (allocation ratio 1:1:1). All patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation and 3, 6 and 12 months after operation, and the (LA) function of left atrium was measured. All ultrasound data will be stored and the professional director of the ultrasound room will be invited to conduct quantitative analysis. Ultrasonic examination indexes include: anterior and posterior diameter of left atrium, left atrial ejection fraction and so on. All patients underwent transesophageal echocardiography before and 3 months after operation. The results were interpreted by 2 experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. Blood samples were taken to detect B-type natriuretic peptide before operation, 1 day, 3-6 months and 12 months after operation. All patients underwent 6-minute walking test and quality of life score before operation and 3, 6 and 12 months after operation. At the same time, the thickness of crest in all patients was measured during operation. This study will clarify the changes of left atrial function and quality of life in patients with atrial fibrillation after LAAC. In addition, this study also observed the effect of radiofrequency ablation combined with LAAC on left atrial function and evaluated whether one-stop surgery was superior to simple occlusion or ablation, and the above results were analyzed. The patients were followed up for an average of one year, and the changes of left atrial function, quality of life and embolic events were analyzed.

Registry
clinicaltrials.gov
Start Date
February 28, 2020
End Date
September 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ruiqin xie
Responsible Party
Sponsor Investigator
Principal Investigator

Ruiqin xie

director of cardiology department

The Second Hospital of Hebei Medical University

Eligibility Criteria

Inclusion Criteria

  • sustained AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old, Cha2ds2-vasc score ≥2, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria

  • Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Outcomes

Primary Outcomes

Left atrial function of postoperative left atrial appendage occlusion detected

Time Frame: 1-12 months

Transthoracic echocardiography

quality of life score test

Time Frame: 1-12 months

quality of life assessed

6-minute walking test

Time Frame: 1-12 months

quality of life assessed

Secondary Outcomes

  • residual shunt and DRT after transcatheter closure of left atrial appendage detected(1-12 months)
  • B natriuretic peptide assessed(1-12 months)

Study Sites (1)

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