NCT06630936 Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
| NCT ID | NCT06630936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Atrial Fibrillation (AF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-09-27 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jianan Wang, Dorctor
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT06630936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06630936 currently recruiting?
Yes, NCT06630936 is actively recruiting participants. Contact the research team at liuxb@zju.edu.cn for enrollment information.
Where is the NCT06630936 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06630936 clinical trial?
NCT06630936 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Jianan Wang, Dorctor at Second Affiliated Hospital of Zhejiang University, School of Medicine. The trial plans to enroll 500 participants.
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