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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
The 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.
After 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.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University third hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGShenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGZhengzhou University People's Hospital, Henan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
NOT_YET_RECRUITINGXijing Hospital, Air Force Medical University
Xi’an, Shanxi, China
NOT_YET_RECRUITINGTaizhou First People's Hospital
Taizhou, Zhejiang, China
NOT_YET_RECRUITINGFreedom 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
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
AF burden
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period.
Time frame: 12 months
Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM
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 in patients with successful EI-VOM.
Time frame: 12 months
AF burden in patients with successful EI-VOM
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period in patients with successful EI-VOM
Time frame: 12 months
Freedom from AF/AFL/AT after multiple procedures
Freedom from any documented atrial arrhythmia \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.
Time frame: 12 months
Freedom from AF after multiple procedures
Freedom from any documented AF \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.
Time frame: 12 months
Freedom from AFL/AT after multiple procedures
Freedom from any documented AFL/AT \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.
Time frame: 12 months
AF burden after multiple procedures
AF burden (% time) on continuous monitoring during 12 months (after the 3-months blanking period) after multiple procedures
Time frame: 12 months
Hospitalization for cardiovascular disease
Hospitalization for cardiovascular disease (e.g., atrial arrhythmia, heart failure and coronary heart disease)
Time frame: 12 months
AFEQT score change between baseline and 12-month
Quality of life assessed by AF effect on quality-of-life (AFEQT) questionnaire
Time frame: 12 months
EQ-5D-5L score change between baseline and 12-month
Quality of life assessed by EuroQol 5-dimension (EQ-5D-5L) scale
Time frame: 12 months
Incidence of procedural complications
Cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, death, stroke / thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
Time frame: Within 3 months after the procedure
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