Evaluating treatments for atrial fibrillation and related mitral regurgitation
Prospective Multi-Center Cohort Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
This study is testing whether catheter ablation or standard medication can help improve mitral regurgitation in patients with atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06630936 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the improvement of mitral regurgitation in patients with atrial fibrillation who also have atrial functional mitral regurgitation. It involves a multicenter cohort of patients who will either undergo catheter ablation or receive standard medical therapy based on clinical judgment or patient preference. The study will evaluate the impact of these treatments on the severity of mitral regurgitation and the size of the left atrium. A total of 500 patients will be enrolled to gather comprehensive data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic paroxysmal atrial fibrillation and moderate to severe mitral regurgitation.
Not a fit: Patients with atrial fibrillation caused by reversible factors or those with significant mitral stenosis or other severe cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with atrial fibrillation and functional mitral regurgitation, potentially enhancing their quality of life.
How similar studies have performed: Previous studies have indicated that restoring sinus rhythm through catheter ablation can significantly reduce mitral regurgitation, suggesting a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 80 years old; 2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history \< 5 years) 3. Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD\<55 mm, and normal LV wall systolic function 4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol Exclusion Criteria: 1. Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors 2. Active endocarditis or active rheumatic heart disease, or degenerative mitral regurgitation due to endocarditis or rheumatic valvular heart disease 3. Moderate to severe mitral stenosis 4. Imaging examination shows left atrium or left atrial appendage thrombosis 5. Left ventricular ejection fraction less than 50% 6. Left atrial diameter more than 50mm 7. Patients with previous left atrial appendage occlusion or left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure or repair (only applied for patients who need to ablation) 8. Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker 9. Previous metal artificial valve or valve repair device implantation (only applied for patients who need to ablation) 10. Presence of lateral thrombus, tumors or other abnormalities that interfere with vascular puncture or catheter operation (only applied for patients who need to ablation) 11. Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities 12. Acute systemic infection 13. Female patients who are pregnant, lactating, or unable to use contraception during the study 14. Patients' life expectancy is less than 12 months 15. Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jianan Wang, Dorctor — Second Affiliated Hospital of Zhejiang University, School of Medicine
- Study coordinator: Xianbao Liu, Dorctor
- Email: liuxb@zju.edu.cn
- Phone: 086-571-87784705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.