CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
NCT ID: NCT06516822
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
320 participants
INTERVENTIONAL
2024-07-31
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF
NCT03448562
Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation
NCT01716143
CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation
NCT01686542
CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
NCT06499818
Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation
NCT06145906
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CPVI-MLA
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).
CPVI-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.
CPVI only
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.
CPVI 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CPVI-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.
CPVI 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. AF duration 1-3 years;
3. Age 18 - 75 years;
4. Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
5. AF recorded within 3 years of enrollment;
6. Patient willing and able to comply with protocol and sign informed consent
Exclusion Criteria
2. Persistent AF lasting \< 1 year or \>3 years;
3. Left atrial thrombosis;
4. Patients with a history of catheter ablation for AF;
5. Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
6. LAD \> 55mm on long axis parasternal view;
7. Left ventricular ejection fraction (LVEF) \< 40%;
8. Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
9. One-stop procedure for AF ablation and left atrial appendage occlusion;
10. Alcohol allergy or contrast agent allergy;
11. Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
12. Pulmonary artery systolic pressure \> 50mmHg;
13. Patients with unstable angina pectoris;
14. Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
15. Patients who had undergone surgery within 6 months;
16. Patients ready to receive heart transplantation;
17. Patients with a history of thromboembolism within 6 months;
18. Patients with diagnosed atrial myxoma;
19. Patients with severe respiratory diseases;
20. Patients with infectious diseases in active phase;
21. Patients with poorly controlled systemic immune diseases;
22. Patients with uncured malignant hematological diseases;
23. Patients with uncured malignant solid tumors;
24. Patients with untreated hypothyroidism or hyperthyroidism;
25. Patients with severe liver dysfunction (elevation of transaminases \[ALT or AST\] \>3 times the upper limit of normal range);
26. Patients with end-stage renal failure requiring dialysis;
27. Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
28. Pregnant and lactating women;
29. Patients with psychiatric ailments;
30. BMI \< 18.5 or ≥ 30kg/m2;
31. Life expectancy \< 2 years;
32. Patients unwilling or unable to give informed consent;
33. Patients unwilling or unable to cooperate to complete follow-up.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhang Fengxiang
Deputy Director of Cardiology, Principal Investigator, Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fengxiang Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University third hospital
Beijing, Beijing Municipality, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
Shenzhen, Guangdong, China
Zhengzhou University People's Hospital, Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Xijing Hospital, Air Force Medical University
Xi’an, Shanxi, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-SR-027.A1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.