Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Long-standing Persistent Atrial Fibrillation
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 320
- Locations
- 10
- Primary Endpoint
- Freedom from any documented atrial arrhythmia off AADs
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Zhang Fengxiang
Deputy Director of Cardiology, Principal Investigator, Clinical Professor
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;
- •AF duration 1-3 years;
- •Age 18 - 75 years;
- •Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
- •AF recorded within 3 years of enrollment;
- •Patient willing and able to comply with protocol and sign informed consent
Exclusion Criteria
- •Paroxysmal atrial fibrillation;
- •Persistent AF lasting \< 1 year or \>3 years;
- •Left atrial thrombosis;
- •Patients with a history of catheter ablation for AF;
- •Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
- •LAD \> 55mm on long axis parasternal view;
- •Left ventricular ejection fraction (LVEF) \< 40%;
- •Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
- •One-stop procedure for AF ablation and left atrial appendage occlusion;
- •Alcohol allergy or contrast agent allergy;
Outcomes
Primary Outcomes
Freedom from any documented atrial arrhythmia off AADs
Time Frame: 12 months
Freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) \> 30 seconds assessed by ECG and Holter after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), after the index ablation procedure
Secondary Outcomes
- Freedom from AFL/AT after multiple procedures(12 months)
- AFEQT score change between baseline and 12-month(12 months)
- Freedom from any documented atrial arrhythmia on/off AADs(12 months)
- Freedom from any documented AF on/off AADs(12 months)
- AF burden(12 months)
- Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM(12 months)
- AF burden in patients with successful EI-VOM(12 months)
- AF burden after multiple procedures(12 months)
- Freedom from any documented AFL/AT on/off AADs(12 months)
- EQ-5D-5L score change between baseline and 12-month(12 months)
- Freedom from AF/AFL/AT after multiple procedures(12 months)
- Freedom from AF after multiple procedures(12 months)
- Hospitalization for cardiovascular disease(12 months)
- Incidence of procedural complications(Within 3 months after the procedure)