Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06438692 |
| Other study ID # |
05949801 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2022 |
| Est. completion date |
June 16, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Qianfoshan Hospital |
| Contact |
Hesheng Hu |
| Phone |
13589112300 |
| Email |
hyperhhs[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
(1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous
ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure;
(2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation
complicated with heart failure.
Description:
2C3L ablation strategy: The electroanatomical mapping system was the Carto 3 V6 system of
Johnson & Johnson, and the high-density mapping electrode (Pentaray) and cold saline
perfusion pressure catheter (ST-SF) were used for ablation. Ablation parameters were set as
follows: ablation power of 45 to 50 Watts (reduced to 25 Watts in the coronary vein and 35
Watts in the endocardium of the mitral isthmus), upper temperature limit of 43 ° C, and
saline infusion rate of 15 mL/ min (changed to 30 mL/min in coronary veins), the pressure was
controlled at 5-15 g, and the target AI was set: 480-500 for the anterior wall of the
pulmonary vein, 350-380 for the posterior wall, 450 for the top of the left atrium, 600 for
the mitral valve isthmus, and 450 for the tricuspid valve isthmus. A single catheter
procedure was performed in the left atrium, and the ablation endpoint was to achieve
continuous bilateral circumferential pulmonary vein damage with loss of intrapulmonary vein
potential, which was further confirmed after conversion to sinus rhythm. During left
pulmonary vein ablation, the top and posterior wall of left pulmonary vein were ablated
first. If pulmonary vein isolation was achieved, no further intervention was performed on the
anterior edge of left pulmonary vein. The ablation of the mitral annulus started from about 1
cm away from the junction between the VOM and the coronary vein, and continued to the
low-voltage area. Ablation was performed in the corresponding epicardium, namely the coronary
vein. Finally, the isthmus of the tricuspid valve was ablated from 6:00 to the inferior vena
cava. If the patient still had atrial fibrillation or atrial flutter after the above
ablation, 200 J direct current was used to cardioversion the sinus rhythm, and the complete
block of each ablation path was verified by pacing during sinus rhythm. In the ablation-only
group, catheter ablation was used only to these end points. The operation time was from the
start of venipuncture to the removal of sheath tube. The melting time was the cumulative
ablation time.
VOM absolute ethanol chemical ablation: The SL1 long sheath was delivered to the opening of
the coronary sinus through the right femoral vein, and the right coronary finger guide tube
(JR4) was placed to the opening of the coronary sinus. The guide tube was rotated clockwise,
and the tip of the guide catheter was pointed in the posterior-superior direction under the
right anterior oblique 30 degree fluoroscopy. The BMW guide wire was sent to the proximal end
of VOM, and the OTW balloon was sent to the middle and distal end of VOM. The balloon was
expanded, and after the BMW guide wire was removed, the course of VOM and whether there was
regurgitation were observed by angiography to ensure the complete occlusion of VOM. Anhydrous
ethanol was injected in fractions via the OTW balloon.
