Actively Recruiting
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-11-08
320
Participants Needed
10
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic long-standing persistent atrial fibrillation lasting at least 1 year, refractory to at least one antiarrhythmic drug
- Atrial fibrillation duration between 1 and 3 years
- Age between 18 and 75 years
- Left atrial diameter between 43 and 55 mm on long axis parasternal view
- Atrial fibrillation recorded within 3 years before enrollment
- Willing and able to comply with the study protocol and sign informed consent
You will not qualify if you...
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation lasting less than 1 year or more than 3 years
- Presence of left atrial thrombosis
- History of catheter ablation for atrial fibrillation
- Severe structural heart disease including severe valvular disease, hypertrophic or dilated cardiomyopathy
- Left atrial diameter greater than 55 mm on long axis parasternal view
- Left ventricular ejection fraction below 40%
- Contraindications to low molecular weight heparin, warfarin, or novel oral anticoagulants
- Concurrent procedure for atrial fibrillation ablation and left atrial appendage occlusion
- Allergy to alcohol or contrast agents
- Use of cephalosporin antibiotics within 72 hours prior to ablation
- Pulmonary artery systolic pressure above 50 mmHg
- Unstable angina pectoris
- Percutaneous coronary intervention within 3 months
- Surgery within 6 months
- Planned heart transplantation
- History of thromboembolism within 6 months
- Diagnosed atrial myxoma
- Severe respiratory diseases
- Active infectious diseases
- Poorly controlled systemic immune diseases
- Untreated malignant hematologic or solid tumors
- Untreated thyroid disorders
- Severe liver dysfunction with elevated transaminases more than 3 times normal
- End-stage renal failure requiring dialysis
- Serious arrhythmias such as ventricular tachycardia with instability
- Pregnancy or lactation
- Psychiatric illnesses
- Body mass index less than 18.5 or 30 kg/m2 or more
- Life expectancy less than 2 years
- Unwillingness or inability to give informed consent or complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
2
Peking University third hospital
Beijing, Beijing Municipality, China, Beijing
Not Yet Recruiting
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510235
Not Yet Recruiting
4
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
Shenzhen, Guangdong, China, 518000
Not Yet Recruiting
5
Zhengzhou University People's Hospital, Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
6
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
7
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
Not Yet Recruiting
8
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250013
Not Yet Recruiting
9
Xijing Hospital, Air Force Medical University
Xi’an, Shanxi, China, 710032
Not Yet Recruiting
10
Taizhou First People's Hospital
Taizhou, Zhejiang, China, 318050
Not Yet Recruiting
Research Team
Y
Yan Dong, MD
CONTACT
Q
Qiushi Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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