Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation (NCT06630936) | Clinical Trial Compass
RecruitingNot Applicable
Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation
China500 participantsStarted 2024-09-27
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged 18 to 80 years old;
✓. Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history \< 5 years)
✓. Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD\<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
Exclusion criteria
✕. 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)
What they're measuring
1
Improvement in MR
Timeframe: 3-month, 6-month, 12-month at follow-up
Trial details
NCT IDNCT06630936
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University