Heart procedure comparison for long-lasting irregular heartbeat in adults
Compares two catheter ablation approaches in adults with long-standing persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Key facts
- Where
- Beijing, Dalian, Guangzhou, Jinan, Nanjing, Shenzhen, Taizhou, Xi’an, and Zhengzhou, ChinaSee the 10 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with long-standing persistent atrial fibrillation (an irregular heartbeat lasting 1 to 3 years) with symptoms despite medicine. It compares two catheter ablation methods.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Long-standing persistent atrial fibrillation: a continuous episode of at least 1 year, with AF duration 1-3 years and AF recorded within 3 years of enrollment. Left atrial diameter 43-55 mm.
- Earlier treatment
- Symptoms must continue despite at least one antiarrhythmic drug. People who had a catheter ablation for AF before cannot join.
Main reasons for not taking part
- Paroxysmal AF, or persistent AF lasting less than 1 year or more than 3 years
- Earlier catheter ablation for AF
- Severe structural heart disease
- Left ventricular ejection fraction below 40%
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06516822, who can take part
Where in China
- Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
- Peking University Third HospitalBeijing, ChinaNot yet recruiting
- The First Affiliated Hospital of Dalian Medical UniversityDalian, ChinaNot yet recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of Shandong First Medical UniversityJinan, ChinaNot yet recruiting
- The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical ScienceShenzhen, ChinaNot yet recruiting
- Taizhou First People's HospitalTaizhou, ChinaNot yet recruiting
- Xijing Hospital, Air Force Medical UniversityXi’an, ChinaNot yet recruiting
- Zhengzhou University People's Hospital, Henan Provincial People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06516822
- Record updated
- 8 November 2024
- Original description
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial.Read full original descriptionShow less
Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial.
The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.
Inclusion: 1. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year; AF duration 1-3 years; Age 18 - 75 years; Left atrial diameter (LAD) 43-55 mm on long axis parasternal view; AF recorded within 3 years of enrollment; Patient willing and able to comply with protocol and sign informed consent.
Exclusion: Patients taking cephalosporin antibiotics within 72 hours prior to ablation; Patients who had undergone surgery within 6 months; Left atrial thrombosis; Patients with a history of catheter ablation for AF; Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.); Alcohol allergy or contrast agent allergy; Patients with unstable angina pectoris; Patients ready to receive heart transplantation; Patients with a history of thromboembolism within 6 months; Patients with severe respiratory diseases; Patients with infectious diseases in active phase; Patients with poorly controlled systemic immune diseases; Patients with uncured malignant hematological diseases; Patients with uncured malignant solid tumors; Patients with end-stage renal failure requiring dialysis; Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability; Patients with psychiatric ailments; Left ventricular ejection fraction (LVEF) < 40%; Patients with severe liver dysfunction (elevation of transaminases [ALT or AST] >3 times the upper limit of normal range); Persistent AF lasting < 1 year or >3 years; Life expectancy < 2 years; Paroxysmal atrial fibrillation; LAD > 55mm on long axis parasternal view; Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants; One-stop procedure for AF ablation and left atrial appendage occlusion; Pulmonary artery systolic pressure > 50mmHg; Patients who had undergone percutaneous coronary intervention (PCI) within 3 months; Patients with diagnosed atrial myxoma; Patients with untreated hypothyroidism or hyperthyroidism; Pregnant and lactating women; BMI < 18.5 or ≥ 30kg/m2; Patients unwilling or unable to give informed consent; Patients unwilling or unable to cooperate to complete follow-up.