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

NCT07085650 | Recruiting DMC

• 1 other identifier: CARE-AF STUDY
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Mitral Regurgitation; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation

  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.

  3 months after atrial fibrillation ablation

Other Outcomes (1)

• mitral or tricuspid regurgitation improvement

  3 months after atrial fibrillation ablation

Study Arms (1)

AF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Atrial fibrillation population in China

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Valve Diseases

Central Study Contacts

Chunyan Ma, Doctor

CONTACT

13998816448; cmu1h_mcy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: July 25, 2025
• Study Start: December 30, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)