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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

Sponsor
The Second Hospital of Hebei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04693871
Collaborator
(none)
100
Enrollment
1
Location
12
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Transesophageal ultrasound

Study Design

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 :
Jan 1, 2020
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the structure of the left atrium [1year]

      Measure the left atrial transverse diameter, anteroposterior diameter, upper and lower diameter.

    2. Changes in the function of the left atrium [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000

    Sponsors and Collaborators

    • The Second Hospital of Hebei Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jan 5, 2021
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Mar 18, 2021