Status:
RECRUITING
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Long-standing Persistent Atrial Fibrillation
Ablation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 circumferent...
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. Th...
Eligibility Criteria
Inclusion
- 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;
- AF recorded within 3 years of enrollment;
- Patient willing and able to comply with protocol and sign informed consent
Exclusion
- 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;
- Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
- Pulmonary artery systolic pressure \> 50mmHg;
- Patients with unstable angina pectoris;
- Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
- Patients who had undergone surgery within 6 months;
- Patients ready to receive heart transplantation;
- Patients with a history of thromboembolism within 6 months;
- Patients with diagnosed atrial myxoma;
- Patients with severe respiratory diseases;
- Patients with infectious diseases in active phase;
- Patients with poorly controlled systemic immune diseases;
- Patients with uncured malignant hematological diseases;
- Patients with uncured malignant solid tumors;
- Patients with untreated hypothyroidism or hyperthyroidism;
- Patients with severe liver dysfunction (elevation of transaminases \[ALT or AST\] \>3 times the upper limit of normal range);
- Patients with end-stage renal failure requiring dialysis;
- Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
- Pregnant and lactating women;
- Patients with psychiatric ailments;
- BMI \< 18.5 or ≥ 30kg/m2;
- Life expectancy \< 2 years;
- Patients unwilling or unable to give informed consent;
- Patients unwilling or unable to cooperate to complete follow-up.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06516822
Start Date
July 31 2024
End Date
December 1 2027
Last Update
November 8 2024
Active Locations (10)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Peking University third hospital
Beijing, Beijing Municipality, China, Beijing
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510235
4
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
Shenzhen, Guangdong, China, 518000