Actively Recruiting
Prospective Multi-Center Cohort Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-11-22
500
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atrial fibrillation causes the atria to lose their normal contraction ability, leading to blood pooling and enlargement of the left atrium. This enlargement can cause dilation of the mitral valve area and mitral regurgitation, called atrial functional mitral regurgitation (AFMR). Researchers are studying how catheter ablation compared to regular drug treatment affects mitral regurgitation in patients with atrial fibrillation combined with AFMR in this prospective, multicenter cohort study. Participants diagnosed with symptomatic paroxysmal atrial fibrillation and moderate to severe mitral regurgitation with normal heart function are enrolled. They are assigned either to receive catheter ablation using pulsed field technology or regular drug therapy based on clinical judgment or personal preference. Follow-up visits to assess changes are scheduled at 3, 6, and 12 months after enrollment. During the study, patients will undergo echocardiography to measure mitral regurgitation severity, left ventricular and atrial function, and arrhythmia recurrence. Researchers will also monitor procedure success and safety events. Quality of life and heart failure-related events are tracked to evaluate the impact of treatments. The entire study period includes multiple follow-ups up to one year after enrollment.
CONDITIONS
Brief Title
Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years old
- Diagnosed with symptomatic paroxysmal atrial fibrillation with less than 5 years history
- Moderate to severe mitral regurgitation with normal left ventricular ejection fraction (≥50%) and left ventricular end-diastolic diameter less than 55 mm
- Able to understand the trial and provide informed consent
- Willing to complete follow-up visits as required
You will not qualify if you...
- Atrial fibrillation caused by reversible factors such as electrolyte imbalances or thyroid disease
- Active endocarditis or rheumatic heart disease, or degenerative mitral regurgitation due to these conditions
- Moderate to severe mitral stenosis
- Presence of left atrium or left atrial appendage thrombosis
- Left ventricular ejection fraction less than 50%
- Left atrial diameter over 50 mm
- Previous left atrial appendage occlusion or closure, patent foramen ovale closure, or atrial septal defect repair if ablation is needed
- Implanted devices like ICD, CRT, or pacemaker
- Previous metal artificial valve or valve repair device implantation if ablation is needed
- Presence of lateral thrombus, tumors, or abnormalities interfering with catheter operation if ablation is needed
- Contraindications to anticoagulation or history of blood clotting or bleeding disorders
- Acute systemic infection
- Pregnant, lactating, or unable to use contraception if female
- Life expectancy less than 12 months
- Other abnormalities or diseases deemed exclusionary by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants who undergo routine care are observed to assess the impact of catheter ablation or drug treatment on mitral regurgitation and atrial fibrillation.
Follow-up visits at 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xianbao Liu, Dorctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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