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Compares treatment options for Long-standing Persistent Atrial Fibrillation
Official title CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
ClinicalTrials.gov ID: NCT06516822
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- Paroxysmal atrial fibrillation;
- Persistent AF lasting \ 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;
See the full eligibility criteria
- 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
- Paroxysmal atrial fibrillation;
- Persistent AF lasting \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Dalian, Liaoning, China
- Jinan, Shandong, China
- Xi’an, Shanxi, China
- Taizhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Zhengzhou, Henan, China; Nanjing, Jiangsu, China; Dalian, Liaoning, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.