RecruitingNCT07129564

Stepwise Strategy for Treatment of Atrialfibrillation Substrate Study

Effects on Sinus Rhythm Maintenance and Atrial Remodeling After Cardioversion of Persistent Atrial Fibrillation: a Prospective, Multi-center, Cohort Study-stepwise Strategy for Treatment of Atrialfibrillation Substrate Study


Sponsor

Yuehui Yin

Enrollment

480 participants

Start Date

Apr 27, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesized that radiofrequency ablation surgery for atrial fibrillation has a higher success rate and a lower recurrence rate of atrial fibrillation in patients with improved atrial stroma. This study is a multicenter, prospective, observational study conducted in China to evaluate whether sacubitril/valsartan can reduce atrial fibrillation recurrence rates, improve cardiac structure and function, and analyze the factors influencing the maintenance rate of sinus rhythm after atrial fibrillation ablation.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Aged 18-80 years, with persistent atrial fibrillation complicated by left atrial enlargement (left atrial anteroposterior diameter 40-50mm); Having the willingness to undergo atrial fibrillation cardioversion and planned to receive amiodarone for pharmacological cardioversion; Having signed a written informed consent form for participation in the study; Not concurrently participating in any other interventional studies.

Exclusion Criteria6

  • Females who are pregnant, lactating, or planning to have children within the next 2 years; Patients whose arrhythmia fails to convert to sinus rhythm with medication and who refuse electrical cardioversion; Patients whose arrhythmia cannot be converted to sinus rhythm with either medication or electrical cardioversion; Glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² (calculated by the CKD-EPI formula); Patients with biliary cirrhosis or cholestasis; Hyperthyroidism; A history of bradycardia (heart rate \< 50 beats/min) or atrioventricular block of second degree or higher; Sick sinus syndrome; Known allergy to iodine, amiodarone, or any of its excipients; Concomitant use of other drugs that prolong the QT interval, or a history of torsades de pointes; Contraindications to atrial fibrillation cardioversion, such as cardiac thrombosis or contraindications to anticoagulation;
  • A history or current presence of the following diseases or conditions:
  • Moderate to severe rheumatic heart disease, valvular heart disease; a history of atrial-related surgery, including valve replacement, radiofrequency ablation for atrial fibrillation/atrial tachycardia/atrial flutter, atrial septal defect occlusion, or complex congenital heart disease surgery;
  • A history of myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months;
  • NYHA Class III-IV congestive heart failure or EF \< 40%;
  • Patients judged by the investigator to have poor compliance, inability to complete the study as required, or an expected lifespan of less than 1 year.

Interventions

OTHERtreatment react

Reverse remodeling of the LA was defined as at least a 15% reduction in the max LA volume after electrical or pharmacological cardioversion for 3 months


Locations(1)

the second affiliated hospital of CQMU

Chongqing, China

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NCT07129564


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