Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation

Recruiting now

Conditions studied: Atrial Fibrillation (AF), Atrial Functional Mitral Regurgitation

In brief

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.

Key facts

Study ID: NCT06630936
Run by: Second Affiliated Hospital, Zhejiang University, School of Medicine
People needed: 500
Starts: 2024-09-27
Expected to finish: 2026-09-30
Last updated by the study team: 2024-11-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients aged 18 to 80 years old;
Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history \&lt; 5 years)
Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD\&lt;55 mm, and normal LV wall systolic function
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

You may not qualify if…

Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors
Active endocarditis or active rheumatic heart disease, or degenerative mitral regurgitation due to endocarditis or rheumatic valvular heart disease
Moderate to severe mitral stenosis
Imaging examination shows left atrium or left atrial appendage thrombosis
Left ventricular ejection fraction less than 50%
Left atrial diameter more than 50mm
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)
Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker
Previous metal artificial valve or valve repair device implantation (only applied for patients who need to ablation)
Presence of lateral thrombus, tumors or other abnormalities that interfere with vascular puncture or catheter operation (only applied for patients who need to ablation)
Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities
Acute systemic infection
Female patients who are pregnant, lactating, or unable to use contraception during the study
Patients' life expectancy is less than 12 months
Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study

Where it is running

Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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