RECRUITINGOBSERVATIONAL
Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
Prospective Multi-Center Cohort Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
About This Trial
To evaluate the improvement of mitral regurgitation after catheter ablation of atrial fibrillation or regular drug therapy in atrial fibrillation patients combined with atrial functional mitral regurgitation.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form 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
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (1)
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China