Stepwise Strategy for Treatment of Atrialfibrillation Substrate Study

Launched by YUEHUI YIN · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating atrial fibrillation, which is an irregular heartbeat that can cause health problems. The study is looking at whether a medicine called sacubitril/valsartan can help lower the chances of atrial fibrillation coming back after a common treatment called ablation surgery. The researchers also want to see if this medicine can improve the structure and function of the heart, especially the left atrium, which is often affected by atrial fibrillation.

People who may be eligible for this study are adults between 18 and 80 years old who have persistent atrial fibrillation along with an enlarged left atrium. Participants should be willing to try treatments to restore their normal heart rhythm, including medication and possibly electrical cardioversion (a procedure that uses a small electric shock to reset the heartbeat). If you join, you can expect to receive careful monitoring to see how well the treatment works, and you’ll be followed over time to check your heart’s health and rhythm. The study is currently recruiting patients in China and excludes people with certain serious health conditions or who cannot safely undergo the treatments involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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:
• • 1. 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;
• • 2. A history of myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months;
• • 3. NYHA Class III-IV congestive heart failure or EF \< 40%;
• • 4. 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.