CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Paroxysmal atrial fibrillation;

Persistent AF lasting < 1 year or >3 years;

Left atrial thrombosis;

Patients with a history of catheter ablation for AF;

Trial design

Treatments tested in this trial

  • CPVI-MLA
  • CPVI only

Treatment groups

320 Participants
are divided into 2 treatment groups

Locations

10
Beijing Anzhen Hospital, Capital Medical University100029, BeijingBeijing Municipality, China
Peking University third hospitalBeijing, BeijingBeijing Municipality, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University510235, GuangzhouGuangdong, China
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science518000, ShenzhenGuangdong, China

Sponsors and collaborators

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor