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OpenTrials
Completed

NCT Number: NCT04693871

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transesophageal ultrasound

Device

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.