CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

NARecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Long-standing Persistent Atrial FibrillationAblation
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (10)

100029

NOT_YET_RECRUITING

Beijing Anzhen Hospital, Capital Medical University, Beijing

116011

NOT_YET_RECRUITING

The First Affiliated Hospital of Dalian Medical University, Dalian

210029

RECRUITING

The First Affiliated Hospital of Nanjing Medical University, Nanjing

250013

NOT_YET_RECRUITING

The First Affiliated Hospital of Shandong First Medical University, Jinan

318050

NOT_YET_RECRUITING

Taizhou First People's Hospital, Taizhou

450003

RECRUITING

Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou

510235

NOT_YET_RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

518000

NOT_YET_RECRUITING

Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science, Shenzhen

710032

NOT_YET_RECRUITING

Xijing Hospital, Air Force Medical University, Xi’an

Beijing

NOT_YET_RECRUITING

Peking University third hospital, Beijing

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER