Stepwise Strategy for Treatment of Atrialfibrillation Substrate Study
Recruiting now
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT07129564
- Run by
- Yuehui Yin
- People needed
- 480
- Starts
- 2023-04-27
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2025-08-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- the second affiliated hospital of CQMU — Chongqing, China (enrolling)
Full record on ClinicalTrials.gov
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