NCT06516822Recruiting
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 17 Jul 2024
- Start date
- 31 Jul 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Atrial fibrillation
- NCT number
- NCT06516822
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 31 Jul 2024 to the primary completion date, Dec 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
- Patients who had undergone surgery within 6 months;
Other illness
- 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.);
- Alcohol allergy or contrast agent allergy;
- Patients with unstable angina pectoris;
- Patients ready to receive heart transplantation;
- Patients with a history of thromboembolism within 6 months;
- 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 end-stage renal failure requiring dialysis;
- Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
- Patients with psychiatric ailments;
Lab values
- Left ventricular ejection fraction (LVEF) \< 40%;
- Patients with severe liver dysfunction (elevation of transaminases \[ALT or AST\] \>3 times the upper limit of normal range);
Age
- Persistent AF lasting \< 1 year or \>3 years;
- Life expectancy \< 2 years;
Other
- Paroxysmal atrial fibrillation;
- LAD \> 55mm on long axis parasternal view;
- Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
- One-stop procedure for AF ablation and left atrial appendage occlusion;
- Pulmonary artery systolic pressure \> 50mmHg;
- Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
- Patients with diagnosed atrial myxoma;
- Patients with untreated hypothyroidism or hyperthyroidism;
- Pregnant and lactating women;
- BMI \< 18.5 or ≥ 30kg/m2;
- Patients unwilling or unable to give informed consent;
- Patients unwilling or unable to cooperate to complete follow-up.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Not yet recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| Taizhou First People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Not yet recruiting |
| Xijing Hospital, Air Force Medical University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| Zhengzhou University People's Hospital, Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.