Clinical trial NCT06516822: CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Official title: Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long-standing Persistent Atrial Fibrillation
Ablation
Keywords: long-standing persistent atrial fibrillation
circumferential pulmonary vein isolation
modified linear ablation
arrhythmia-free survival
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Freedom from any documented atrial arrhythmia off AADs
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from any documented atrial arrhythmia on/off AADs
timeFrame: 12 months
measure: Freedom from any documented AF on/off AADs
timeFrame: 12 months
measure: Freedom from any documented AFL/AT on/off AADs
timeFrame: 12 months
measure: AF burden
timeFrame: 12 months
measure: Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM
timeFrame: 12 months
measure: AF burden in patients with successful EI-VOM
timeFrame: 12 months
measure: Freedom from AF/AFL/AT after multiple procedures
timeFrame: 12 months
measure: Freedom from AF after multiple procedures
timeFrame: 12 months
measure: Freedom from AFL/AT after multiple procedures
timeFrame: 12 months
measure: AF burden after multiple procedures
timeFrame: 12 months
measure: Hospitalization for cardiovascular disease
timeFrame: 12 months
measure: AFEQT score change between baseline and 12-month
timeFrame: 12 months
measure: EQ-5D-5L score change between baseline and 12-month
timeFrame: 12 months
measure: Incidence of procedural complications
timeFrame: Within 3 months after the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University third hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
state: Guangdong
city: Zhengzhou
country: China
facility: Zhengzhou University People's Hospital, Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: DaLian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: JiNan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital, Air Force Medical University
state: Shanxi
city: Taizhou
country: China
facility: Taizhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Fengxiang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: