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Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion

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ClinicalTrials.gov Identifier: NCT04693871
Recruitment Status : Completed
First Posted : January 5, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Ruiqin xie, The Second Hospital of Hebei Medical University

Study Description
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Brief Summary:
Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure can not only improve symptoms in patients with non-valvular atrial fibrillation, but also prevent left atrial appendage thrombosis. The safety and effectiveness of left atrial appendage occlusion have been confirmed by randomized controlled trials and actual experience. Among patients with different left atrial appendage emptying speeds, there are limited studies on the structure and function of the left atrial appendage after LAA closure. In this study, patients with persistent nonvalvular atrial fibrillation were selected for radiofrequency ablation combined with LAA closure. The sinus rhythm was restored after the operation. According to the different emptying speed of the left atrial appendage, they were divided into a high-flow rate group and a low-flow rate group. The differences in the structure and function of the left atrium between the two groups were analyzed.

Condition or disease Intervention/treatment
Left Atrial Appendage Velocity Left Atrial Structure Left Atrial Function Device: Transesophageal ultrasound

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion.
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
high-flow rate group Device: Transesophageal ultrasound
Patients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds.
Other Name: Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure
low-flow rate group Device: Transesophageal ultrasound
Patients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds.
Other Name: Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the structure of the left atrium [ Time Frame: 1year ]
    Measure the left atrial transverse diameter, anteroposterior diameter, upper and lower diameter.

  2. Changes in the function of the left atrium [ Time Frame: 1year ]
    Left atrium volume. Two-chamber and four-chamber left atrium strain and strain rate, left atrium storage function, channel function and pump function.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with non-valvular atrial fibrillation between the ages of 18 and 80 received atrial fibrillation radiofrequency ablation combined with left atrial appendage occlusion, and recovered to sinus rhythm after the operation. According to the different left atrial appendage emptying speed, it is divided into a higher left atrial appendage emptying speed group and a lower left atrial appendage emptying speed group.
Criteria

Inclusion Criteria:

  • Patients who received atrial fibrillation radiofrequency ablation combined with left atrial appendage closure.

Exclude Criteria

  • Patients with incomplete data.
  • Device embolism.
  • Residual shunt around the device found by transesophageal echocardiography greater than 5 mm.
  • Mitral valve stenosis.
  • Artificial valve.
  • Atrial septal defect.
  • Dilated cardiomyopathy
  • Moderate Severe mitral regurgitation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693871


Locations
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China, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Sponsors and Collaborators
The Second Hospital of Hebei Medical University
More Information
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Responsible Party: Ruiqin xie, Director of the Department of Cardiology in the Second Hospital of Hebei Medical University, The Second Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT04693871    
Other Study ID Numbers: XieRuiqinLAAEV
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes