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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

Study contacts

• Principal investigator: Fengxiang Zhang, MD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Yan Dong, MD
• Email: dy_medical@163.com
• Phone: +86 18651908170

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.