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

NCT06516822 | Recruiting DMC

• 1 other identifier: 2023-SR-027.A1
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 10

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 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.

Conditions

Long-standing Persistent Atrial Fibrillation; Ablation

Keywords

long-standing persistent atrial fibrillation; circumferential pulmonary vein isolation; modified linear ablation; arrhythmia-free survival

Outcome Measures

Primary Outcomes (1)

• Freedom from any documented atrial arrhythmia off AADs

  Freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) \> 30 seconds assessed by ECG and Holter after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), after the index ablation procedure

  12 months

Secondary Outcomes (14)

• Freedom from any documented atrial arrhythmia on/off AADs

  12 months

• Freedom from any documented AF on/off AADs

  12 months

• Freedom from any documented AFL/AT on/off AADs

  12 months

• AF burden

  12 months

• Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM

  12 months

Study Arms (2)

CPVI-MLA

EXPERIMENTAL

Patients randomized to the CPVI-MLA group first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI).

Procedure: CPVI-MLA

CPVI only

ACTIVE COMPARATOR

Patients randomized to the CPVI group undergo right PV ablation, followed by the left PV ablation. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia in a wide-area circumferential pattern. Complete CPVI is achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.

Procedure: CPVI only

Interventions

CPVI-MLA PROCEDURE

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.

CPVI-MLA

CPVI only PROCEDURE

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.

CPVI only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (10)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

Peking University third hospital

Beijing, Beijing Municipality, Beijing, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510235, China

NOT YET RECRUITING

Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science

Shenzhen, Guangdong, 518000, China

NOT YET RECRUITING

Zhengzhou University People's Hospital, Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

NOT YET RECRUITING

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250013, China

NOT YET RECRUITING

Xijing Hospital, Air Force Medical University

Xi’an, Shanxi, 710032, China

NOT YET RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, 318050, China

NOT YET RECRUITING

Study Officials

• Fengxiang Zhang, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Dong, MD

CONTACT

+86 18651908170; dy_medical@163.com

Qiushi Chen, MD

CONTACT

chenqs918@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Cardiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)