Ablation, Long-standing Persistent Atrial Fibrillation
Conditions
Keywords
long-standing persistent atrial fibrillation, circumferential pulmonary vein isolation, modified linear ablation, arrhythmia-free survival
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.
Detailed description
The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time. All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 1:1 ratio. The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM, 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). The follow-up is for a minimum of 12 months with rhythm monitoring. The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) \> 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), at 12 months after the index ablation procedure.
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 1\. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year; 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
1. Paroxysmal atrial fibrillation; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from any documented atrial arrhythmia off AADs | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from any documented AF on/off AADs | 12 months | Freedom from any documented AF episodes \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs. |
| Freedom from any documented AFL/AT on/off AADs | 12 months | Freedom from any documented AFL/AT episodes \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs. |
| AF burden | 12 months | AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period. |
| Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM | 12 months | Freedom from any documented AFL/AT episodes \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs in patients with successful EI-VOM. |
| AF burden in patients with successful EI-VOM | 12 months | AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period in patients with successful EI-VOM |
| Freedom from AF/AFL/AT after multiple procedures | 12 months | Freedom from any documented atrial arrhythmia \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs. |
| Freedom from any documented atrial arrhythmia on/off AADs | 12 months | Freedom from any documented atrial arrhythmia \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs. |
| Freedom from AFL/AT after multiple procedures | 12 months | Freedom from any documented AFL/AT \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs. |
| AF burden after multiple procedures | 12 months | AF burden (% time) on continuous monitoring during 12 months (after the 3-months blanking period) after multiple procedures |
| Hospitalization for cardiovascular disease | 12 months | Hospitalization for cardiovascular disease (e.g., atrial arrhythmia, heart failure and coronary heart disease) |
| AFEQT score change between baseline and 12-month | 12 months | Quality of life assessed by AF effect on quality-of-life (AFEQT) questionnaire |
| EQ-5D-5L score change between baseline and 12-month | 12 months | Quality of life assessed by EuroQol 5-dimension (EQ-5D-5L) scale |
| Incidence of procedural complications | Within 3 months after the procedure | Cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, death, stroke / thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula). |
| Freedom from AF after multiple procedures | 12 months | Freedom from any documented AF \> 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs. |
Countries
China
Contacts
Primary ContactYan Dong, MD
Backup ContactQiushi Chen, MD
Outcome results
None listed