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.
1. 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;
Paroxysmal atrial fibrillation;
Persistent AF lasting < 1 year or >3 years;
Left atrial thrombosis;
Patients with a history of catheter ablation for AF;
Parallel
CPVI-MLA
Procedure/SurgeryThe details include: (1) EI-VOM procedure: An 8.5-French-long sheath is inserted into to the CS via the femoral vein. A JR4 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a guide wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated at 6-8 atm pressure in the VOM. Ethanol is infused into VOM from distal to proximal with 3ml each time within 1-2min. After the distal EI-VOM, the balloon is deflated and adjusted to the middle part of VOM. The EI-VOM procedure in the proximal and middle part of VOM should be the same as that in the distal. After three times of EI-VOM, the contrast is injected into VOM to make it permeable and dispersed to observe the effect of alcohol ablation. (2) After EI-VOM, radiofrequency ablation is performed to achieve bilateral PVI, PWI, bidirectional block of MI and CTI, disappearance of LAI-CS potential and SVCI. (3) Any organized AT observed during the procedure is targeted as well.
CPVI only
Procedure/SurgeryAfter reconstructing the left atrial geometry, CPVI is performed. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia for PVI to achieve a wide PVI ring. The mapping catheter PentaRay will be used to confirm the complete isolation of the PV antrum when all PV potentials within each antrum are abolished. If the AF persists after CPVI, direct current cardioversion is then be conducted to restore sinus rhythm. If spontaneous AFL/AT occurs during ablation, ablation is performed targeting the focal or critical isthmus under the guidance of high-density activation mapping. The endpoint of CPVI is to achieve complete entrance and exit block of all PV antra as recorded by PentaRay during sinus rhythm or CS pacing.
Freedom from any documented atrial arrhythmia off AADs
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
Freedom from any documented atrial arrhythmia on/off AADs
Freedom from any documented atrial arrhythmia \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.
Freedom from any documented AF on/off AADs
Freedom from any documented AF episodes \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.
Freedom from any documented AFL/AT on/off AADs
Freedom from any documented AFL/AT episodes \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.
AF burden
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period.
Click on the lead sponsor to view all of their trials.
