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

Last updated: November 6, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Cardiac Disease

Treatment

CPVI only

CPVI-MLA

Clinical Study ID

NCT06516822
2023-SR-027.A1
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 noveloral 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] >3times 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 withhemodynamic 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.

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: CPVI only
Phase:
Study Start date:
July 31, 2024
Estimated Completion Date:
December 31, 2027

Study Description

The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time. All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 1:1 ratio. The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM, CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). The follow-up is for a minimum of 12 months with rhythm monitoring. The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), at 12 months after the index ablation procedure.

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing 100029
    China

    Site Not Available

  • Peking University third hospital

    Beijing, Beijing Beijing
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510235
    China

    Site Not Available

  • Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Zhengzhou University People's Hospital, Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    DaLian, Liaoning 116011
    China

    Site Not Available

  • The First Affiliated Hospital of Shandong First Medical University

    JiNan, Shandong 250013
    China

    Site Not Available

  • Xijing Hospital, Air Force Medical University

    Xi'an, Shanxi 710032
    China

    Site Not Available

  • Taizhou First People's Hospital

    Taizhou, Zhejiang 318050
    China

    Site Not Available

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