RecruitingNot ApplicableNCT06516822

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)

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

320 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Ablation Long-standing Persistent Atrial Fibrillation

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 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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

\. 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 Criteria33

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.

Interventions

PROCEDURECPVI-MLA

The details include: (1) EI-VOM procedure: An 8.5-French-long sheath is inserted into to the CS via the femoral vein. A JR4 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a guide wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated at 6-8 atm pressure in the VOM. Ethanol is infused into VOM from distal to proximal with 3ml each time within 1-2min. After the distal EI-VOM, the balloon is deflated and adjusted to the middle part of VOM. The EI-VOM procedure in the proximal and middle part of VOM should be the same as that in the distal. After three times of EI-VOM, the contrast is injected into VOM to make it permeable and dispersed to observe the effect of alcohol ablation. (2) After EI-VOM, radiofrequency ablation is performed to achieve bilateral PVI, PWI, bidirectional block of MI and CTI, disappearance of LAI-CS potential and SVCI. (3) Any organized AT observed during the procedure is targeted as well.

PROCEDURECPVI only

After reconstructing the left atrial geometry, CPVI is performed. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia for PVI to achieve a wide PVI ring. The mapping catheter PentaRay will be used to confirm the complete isolation of the PV antrum when all PV potentials within each antrum are abolished. If the AF persists after CPVI, direct current cardioversion is then be conducted to restore sinus rhythm. If spontaneous AFL/AT occurs during ablation, ablation is performed targeting the focal or critical isthmus under the guidance of high-density activation mapping. The endpoint of CPVI is to achieve complete entrance and exit block of all PV antra as recorded by PentaRay during sinus rhythm or CS pacing.