CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jul 23, 2024

Keywords

ClinConnect Summary

The SINUS study is a clinical trial that is looking at two different treatment methods for patients with long-standing persistent atrial fibrillation (LSPAF), a heart condition that causes an irregular and often rapid heartbeat. Specifically, the trial compares a standard treatment called circumferential pulmonary vein isolation (CPVI) with a newer approach that adds a modified linear ablation technique (CPVI-MLA). Researchers want to find out if the new method can help patients have fewer episodes of their heart racing and improve their overall health.

To participate in this study, you need to be between 18 and 75 years old and have had LSPAF for at least a year, which hasn't improved with at least one medication. You should also have a specific heart size measured through an ultrasound. If you qualify and choose to join, you can expect to receive either of the two treatments and will be monitored for safety and effectiveness. This study is currently recruiting participants, so it's a good opportunity to contribute to important research that could help improve treatment options for people with this condition.

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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.