CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Recruiting · NCT06516822 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
CPVI onlyCPVI-MLA
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Paroxysmal atrial fibrillation;
- Persistent AF lasting \< 1 year or \>3 years;
- 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.);
- LAD \> 55mm on long axis parasternal view;
- Left ventricular ejection fraction (LVEF) \< 40%;
- Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
- One-stop procedure for AF ablation and left atrial appendage occlusion;
- Alcohol allergy or contrast agent allergy;
- Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
- Pulmonary artery systolic pressure \> 50mmHg;
- Patients with unstable angina pectoris;
- Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
- Patients who had undergone surgery within 6 months;
- Patients ready to receive heart transplantation;
- Patients with a history of thromboembolism within 6 months;
- Patients with diagnosed atrial myxoma;
- 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 untreated hypothyroidism or hyperthyroidism;
- Patients with severe liver dysfunction (elevation of transaminases \[ALT or AST\] \>3 times the upper limit of normal range);
- Patients with end-stage renal failure requiring dialysis;
- Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
- Pregnant and lactating women;
- Patients with psychiatric ailments;
- BMI \< 18.5 or ≥ 30kg/m2;
- Life expectancy \< 2 years;
- Patients unwilling or unable to give informed consent;
- Patients unwilling or unable to cooperate to complete follow-up.
Where it is running
10 locations listed.
- Beijing Anzhen Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Peking University third hospital - Beijing, Beijing Municipality, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science - Shenzhen, Guangdong, China
- Zhengzhou University People's Hospital, Henan Provincial People's Hospital - Zhengzhou, Henan, China
- The First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- The First Affiliated Hospital of Dalian Medical University - Dalian, Liaoning, China
- The First Affiliated Hospital of Shandong First Medical University - Jinan, Shandong, China
- Xijing Hospital, Air Force Medical University - Xi’an, Shanxi, China
- Taizhou First People's Hospital - Taizhou, Zhejiang, China