Stepwise Strategy for Treatment of Atrialfibrillation Substrate Study

NCT07129564 | Recruiting

• 1 other identifier: SAFE study
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• recurrence of atrial tachyarrhythmia

  the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug

  1 year

Study Arms (2)

reversed

at least a 15% reduction in the max LA volume

Other: treatment react

non-reversed

less than 15% reduction in the max LA volume

Interventions

treatment react OTHER

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

reversed

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persistent atrial fibrillation with left atrial enlargement

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.

Sponsors & Collaborators

• Yuehui Yin: lead

Study Sites (1)

the second affiliated hospital of CQMU

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuehui Yin

CONTACT

+8613508335502; yinyh63@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: April 27, 2023
• Primary Completion: November 25, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)