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CompletedNCT04693871Updated Mar 18, 2021

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

An observational study in Left Atrial Appendage Velocity, Left Atrial Structure and Left Atrial Function, sponsored by The Second Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by The Second Hospital of Hebei Medical University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Left Atrial Appendage Velocity
  • Left Atrial Structure
  • Left Atrial Function
03

In context

Lead sponsor

The Second Hospital of Hebei Medical University is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • high-flow rate group

    Device: Transesophageal ultrasound

  • low-flow rate group

    Device: Transesophageal ultrasound

Interventions

  • DeviceTransesophageal 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.

    Also known as: Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure

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What researchers measure

Primary outcomes

  1. Changes in the structure of the left atrium

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

    Time frame: 1year

  2. Changes in the function of the left atrium

    Left atrium volume. Two-chamber and four-chamber left atrium strain and strain rate, left atrium storage function, channel function and pump function.

    Time frame: 1year

07

Study locations

1 site
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04693871
Lead sponsor
The Second Hospital of Hebei Medical University
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) — Principal investigator
First posted
Jan 5, 2021
Start date
Jan 1, 2020
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021
Last update
Mar 18, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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