Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438692
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-01-02
Brief Title:
Ablation Strategies for Persistent Atrial Fibrillation Combined With Heart Failure
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Clinical Study on the 2C3L Strategy Based on Marshall Venous Chemoablation for the Treatment of Persistent Atrial Fibrillation Combined With Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 mLmin 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 600 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None