CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
NCT Number: NCT06516822
Acronym: SINUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long-standing Persistent Atrial Fibrillation|Ablation
Interventions: PROCEDURE: CPVI-MLA|PROCEDURE: CPVI only
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-12
Locations: Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing, 100029, China|Peking University third hospital, Beijing, Beijing, Beijing, China|Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510235, China|Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science, Shenzhen, Guangdong, 518000, China|Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, Henan, 450003, China|The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China|The First Affiliated Hospital of Dalian Medical University, DaLian, Liaoning, 116011, China|The First Affiliated Hospital of Shandong First Medical University, JiNan, Shandong, 250013, China|Xijing Hospital, Air Force Medical University, Xi'an, Shanxi, 710032, China|Taizhou First People's Hospital, Taizhou, Zhejiang, 318050, China

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.

Primary Outcome Measures: 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, 12 months
Secondary Outcome Measures: 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., 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., 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., 12 months|AF burden, AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period., 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., 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, 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., 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., 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., 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, 12 months|Hospitalization for cardiovascular disease, Hospitalization for cardiovascular disease (e.g., atrial arrhythmia, heart failure and coronary heart disease), 12 months|AFEQT score change between baseline and 12-month, Quality of life assessed by AF effect on quality-of-life (AFEQT) questionnaire, 12 months|EQ-5D-5L score change between baseline and 12-month, Quality of life assessed by EuroQol 5-dimension (EQ-5D-5L) scale, 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)., Within 3 months after the procedure