NCT07129564Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 480 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 27 Apr 2023
- Primary completion date
- 25 Nov 2024
- Lead sponsor
- Yuehui Yin
- Diseases
- Atrial fibrillation
- NCT number
- NCT07129564
What you commit to
- Study type: Observational
- Planned participants: 480
- From 27 Apr 2023 to the primary completion date, 25 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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%;
Lab values
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the second affiliated hospital of CQMU Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.