Comparing two methods of catheter ablation for long-standing persistent atrial fibrillation

Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

This study is testing if a new method of heart procedure can help people with long-standing atrial fibrillation feel better compared to a standard procedure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT06516822 on ClinicalTrials.gov

What this trial studies

The SINUS study is a multicenter, randomized trial designed to evaluate the efficacy and safety of circumferential pulmonary vein isolation with modified linear ablation (CPVI-MLA) compared to circumferential pulmonary vein isolation (CPVI) alone in patients with long-standing persistent atrial fibrillation (LSPAF). It will enroll 320 patients who have experienced symptomatic LSPAF and are refractory to at least one antiarrhythmic drug. Participants will be randomly assigned to one of the two treatment groups, and their heart rhythm will be monitored for a minimum of 12 months post-ablation. The primary goal is to achieve freedom from documented atrial arrhythmias without the use of antiarrhythmic drugs after the initial blanking period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with symptomatic long-standing persistent atrial fibrillation lasting 1-3 years, who have not responded to at least one antiarrhythmic drug.

Not a fit: Patients with paroxysmal atrial fibrillation or those with severe structural heart disease are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved long-term outcomes for patients with long-standing persistent atrial fibrillation by reducing recurrence rates of arrhythmias.

How similar studies have performed: Other studies have shown varying success with catheter ablation techniques for atrial fibrillation, but the specific combination of methods in this trial is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 1\. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;
2. AF duration 1-3 years;
3. Age 18 - 75 years;
4. Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
5. AF recorded within 3 years of enrollment;
6. Patient willing and able to comply with protocol and sign informed consent

Exclusion Criteria:

1. Paroxysmal atrial fibrillation;
2. Persistent AF lasting \< 1 year or \>3 years;
3. Left atrial thrombosis;
4. Patients with a history of catheter ablation for AF;
5. Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
6. LAD \> 55mm on long axis parasternal view;
7. Left ventricular ejection fraction (LVEF) \< 40%;
8. Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
9. One-stop procedure for AF ablation and left atrial appendage occlusion;
10. Alcohol allergy or contrast agent allergy;
11. Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
12. Pulmonary artery systolic pressure \> 50mmHg;
13. Patients with unstable angina pectoris;
14. Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
15. Patients who had undergone surgery within 6 months;
16. Patients ready to receive heart transplantation;
17. Patients with a history of thromboembolism within 6 months;
18. Patients with diagnosed atrial myxoma;
19. Patients with severe respiratory diseases;
20. Patients with infectious diseases in active phase;
21. Patients with poorly controlled systemic immune diseases;
22. Patients with uncured malignant hematological diseases;
23. Patients with uncured malignant solid tumors;
24. Patients with untreated hypothyroidism or hyperthyroidism;
25. Patients with severe liver dysfunction (elevation of transaminases \[ALT or AST\] \>3 times the upper limit of normal range);
26. Patients with end-stage renal failure requiring dialysis;
27. Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
28. Pregnant and lactating women;
29. Patients with psychiatric ailments;
30. BMI \< 18.5 or ≥ 30kg/m2;
31. Life expectancy \< 2 years;
32. Patients unwilling or unable to give informed consent;
33. Patients unwilling or unable to cooperate to complete follow-up.

Where this trial is running

Beijing, Beijing Municipality and 9 other locations

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Peking University third hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• Zhengzhou University People's Hospital, Henan Provincial People's Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Xijing Hospital, Air Force Medical University — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Taizhou First People's Hospital — Taizhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Fengxiang Zhang, MD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Yan Dong, MD

Conditions: Long-standing Persistent Atrial Fibrillation, Ablation, long-standing persistent atrial fibrillation, circumferential pulmonary vein isolation, modified linear ablation, arrhythmia-free survival