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NCT Number: NCT07085650

The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the clinic and can lead to valve regurgitation and a poor prognosis. At present, atrial fibrillation ablation is one of the most effective means for the recurrence of atrial fibrillation in clinical practice, but the recurrence rate is high. Therefore, it is of great significance to find the predictors of relapse after atrial fibrillation ablation for clinical precision treatment. three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation.

Therefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location status: Recruiting

About this study

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice. It is characterized by disturbance of atrial electromechanical activity, and the incidence rate of the general population can reach 1.5-2%. Valvular regurgitation may be associated with atrial fibrillation, leading to poor prognosis. However, due to limited screening techniques, it is difficult to comprehensively evaluate valvular regurgitation and its influencing factors. On the other hand, AF may lead to reduced heart function, atrial or auricular thrombosis, and lead to high risk events such as ischemic stroke and heart failure.

Therefore, restoring normal sinus rhythm is of great significance for patients with atrial fibrillation. Atrial fibrillation ablation is one of the most effective methods for atrial fibrillation reversion, which is of great significance for improving the prognosis of patients. However, although the current ablation is very mature and effective, the recurrence rate one year after the first ablation can reach 20 to 40%. The high recurrence rate not only increases the readmission risk of patients and increases the economic burden, but also makes some patients shy away from ablation therapy and delay treatment, resulting in adverse outcomes. At present, there is a lack of effective indicators for predicting the recurrence of atrial fibrillation after ablation in clinical practice. Therefore, it is of great significance to search for predictive factors for the recurrence of atrial fibrillation after ablation in clinical precision treatment.

three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation.

Therefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.

Who can participate

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

Inclusion criteria

  • Age ≥18 years old;
  • Patients who came to the hospital with atrial fibrillation and intended to undergo ablation.

Exclusion criteria

  • - History of left atrial or left atrial appendix thrombus, new cerebral infarction and myocardial infarction (< 6 months);
  • Congenital heart disease, valvular heart disease, dilated heart disease, hypertrophic cardiomyopathy, pacemaker implantation, artificial valve replacement;
  • hyperthyroidism, severe liver and kidney insufficiency;
  • Proposed cardiac pacemaker implantation;
  • Previous history of catheter ablation;
  • The quality of three-dimensional transesophageal images was insufficient and could not be analyzed;
  • refuse to sign the informed consent.

Treatment and study plan

Primary outcomes

  1. Recurrence of atrial fibrillation

    Time frame: 3 months after atrial fibrillation ablation

    Using 12-lead electrocardiogram and 24h-holter electrocardiogram to exam patients. The recurrence of atrial fibrillation is defined as atrial tachycardia, atrial flutter or atrial fibrillation lasting for 30 seconds or more.

Other outcomes

  1. mitral or tricuspid regurgitation improvement

    Time frame: 3 months after atrial fibrillation ablation

    • Utilize three-dimensional ultrasound technology to measure multiple parameters of the mitral valve annulus and tricuspid valve annulus, including annulus area (cm2), circumference (cm), non-planar angle (°), etc. Compare the differences of these parameters with the baseline state at 3 months.
    • Use Doppler technology to assess the improvement or deterioration of mitral and tricuspid regurgitation, including regurgitation diameter (mm), regurgitation area (cm2).

Study contacts

Contact information is provided by the study sponsor or research team.

Chunyan Ma, Doctor

CONTACT

[email protected]

13998816448

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation by 3-dimensional Transoesophageal Echocardiography and Recurrent Events Evaluation

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

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.

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