320
Participants
Start Date
July 31, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
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.
NOT_YET_RECRUITING
Beijing Anzhen Hospital, Capital Medical University, Beijing
NOT_YET_RECRUITING
The First Affiliated Hospital of Dalian Medical University, Dalian
RECRUITING
The First Affiliated Hospital of Nanjing Medical University, Nanjing
NOT_YET_RECRUITING
The First Affiliated Hospital of Shandong First Medical University, Jinan
NOT_YET_RECRUITING
Taizhou First People's Hospital, Taizhou
RECRUITING
Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou
NOT_YET_RECRUITING
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou
NOT_YET_RECRUITING
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science, Shenzhen
NOT_YET_RECRUITING
Xijing Hospital, Air Force Medical University, Xi’an
NOT_YET_RECRUITING
Peking University third hospital, Beijing
The First Affiliated Hospital with Nanjing Medical University
OTHER