A randomized controlled trial for comparing catheter ablation vs. Cox MAZE+mitral valve surgery in the treatment of atrial fibrillation in patients with moderate mitral regurgitation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800017963

Enrollment

Unknown

Registered

2018-08-25

Start date

2018-10-01

Completion date

Unknown

Last updated

2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

A:Catheter ablation

B: Cox MAZE+mitral valve surgery

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Having a history of atrial fibrillation, atrial fibrillation record within 6 months before ablation, atrial fibrillation duration of more than 7 days, can not be terminated by themselves. Atrial fibrillation records include a dynamic electrocardiogram or a 12-lead electrocardiogram; 2. Secondary moderate mitral regurgitation; 3. More than one drug treatment is ineffective or unwilling to long-term drug treatment; 4. Provide informed consent to participate in the study, follow-up trials and assessment procedures; 5. The patient is 18-80 years old.

Exclusion criteria

Exclusion criteria: 1. There are acute lesions, such as acute phase after myocardial infarction (within 3 months), acute heart attack or 3 months after new cerebral infarction; 2. In the heart transplant list; 3. Life expectancy is less than 1 year; 4. There are other bleeding diseases, and anticoagulation therapy cannot be performed; 5. Left atrial thrombus; 6. New York patients with grade 3-4 cardiac dysfunction or EF <40%; 7. Cancer uncontrolled patients; 8. Significant liver and kidney function damage (and / or ALT, AST levels higher than the upper limit of the normal value of 1 times, CCr <50%); 9. Previous radiofrequency catheter ablation was performed in the treatment of atrial fibrillation or cardiac surgery; 10. Women who are pregnant, breast-feeding, who are planning to become pregnant, or women of childbearing age who do not adopt reliable methods of contraception; 11. In addition to mitral regurgitation, there are other history of moderate or severe heart valve disease; 12. Previous history of rheumatic heart disease, infective endocarditis, congenital malformation of the valve, and mitral valve prolapse; 13. Previous history of coronary heart disease and myocardial infarction; 14. Previous history of myocarditis, dilated cardiomyopathy, hypertrophic cardiomyopathy, and restrictive cardiomyopathy.

Design outcomes

Primary

Measure	Time frame
Rate of AF recurrence;Rate of atrial flutter or atrial tachycardia;Changes in the diameter of the left atrium and the left ventricular ejection fraction;	—

Secondary

Measure	Time frame
Incidence of complications;	—

Countries

China

Contacts

Public ContactLiang Zhao

Shanghai Chest Hospital

zhaoliang80112@126.com+86 13564276935

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026